Bpu 22003.qxd - Karger Publishers

26
Keynote Lecture K1 Controversies and Issues in Hemodiafiltration Therapy N.K. Man Department of Nephrology – INSERM U 507 Hospital Necker, Paris, France Hemodiafiltration (HDF) which combines diffusive and convec- tive methods for solutes mass removal should be the most effective technique of renal replacement therapy. However, this established technique had not the foreseen development which it deserved. Several drawbacks of the therapy which are not counter-balanced by significant advantages, are identified for discussion. Compared to the unique simplicity of standard hemodialysis, most of nephrologists are reluctant to use HDF due to its cumbersome operating mode which, in addition, requires more stringent maintenance rules. The extracost of disposable items is also a potent factor in the decision-making. Although technical advances permit to produce on-line substitution fluid, the potential risks and hazards associated with the injection of a contaminated dialysate in the blood stream, do exist. Indeed, pro- duction of ultrapure dialysis fluid, in which endotoxin and bacteria are undetectable, relies on the implementation of ultrafilters on the dial- ysis pathway. However, multiple use of such a sterilizing module allows the formation of biofilm, where bacteria and endotoxins could be then, released in the dialysate and infused to the patient. Single use of ultrafilters is, therefore, mandatory. The availability of high flux hemofilter and the low cost of substitution fluid produced on-line leads to the practice of excessive ultrafiltration flow rates, as high as 300 mL/min, where loss of aminoacids and water soluble vitamines, among other vital substances, should be taken in consideration. Furthermore, infusion of large amount of dialysate containing resid- ual acetate of 2–7 mmol/L could lead to long-term complications. Acetate-free dialysate should be used as substitution fluid in on-line hemodiafiltration. An alternative to these issues could be the HDF technique with on-line regeneration of the ultrafiltrate by adsorption of uremic waste products onto synthetic resin and mineral charcoal. One of the most promising development of HDF remains in its predi- lution mode where dilution of blood increases the free moiety of metabolites bound to proteins, which become available for removal. Pre-dilution mode HDF should be extended in practice since it seems to enhance removal of protein-bound uremic toxins. Clinical investi- gations are then needed to demonstrate the extra-benefits of this tech- nique. Finally, future extension of HDF to standard application depends on studies of large cohort of patients regularly treated with HDF on outcome, in terms of quality of life, morbidity and mortality. Current Topics T1 Expectations toward Daily Hemofiltration H. Kawanishi Tsuchiya General Hospital, Hiroshima, Japan The result of the HEMO study on whether the increase in dialysis dose (Kt/V) would improve the survival rate of patients was published last year. Counter to the expectations, it revealed no difference in the survival rate, even when the spKt/V was increased to more than 1.25 in HD thrice weekly. The results suggest that dialysis needs to be per- formed over a longer period of time and more frequently in order to obtain higher survival rates. Currently, various patterns of daily dial- ysis are being sought, as seen in the development of an HD device for home use by Aksys Co. However, a water treatment system is essen- tial for HD, which is the greatest obstacle for home and continuous dialysis. On the other hand, if a refilling solution becomes available, a water treatment device would not be necessary for hemofiltration, which will make it simple and easy to perform. The Daily HF has made use of this advantage. Basically one session of Daily HF is 1.5 to 2 hours and is performed 6 times weekly. If the filtration volume for 1 session is targeted at weekly Kt/V:2.0, it accounts for 40% of the body fluid volume (V). Because the method is hemofiltration, the removal of large molecular weight substances is performed more effi- ciently than the usual HD. According to our experience over a short period of time, the average removal of urea per unit time was 5.1 mL/min (weekly Kt/V 2.0), and that of 2 MG was 1.6 mL/min. What is needed for Daily HF is a bag of refilling solution, a home delivery system, and an HF device. As these are already on the mar- ket, it will not be difficult to realize this therapy, if the problem of medical costs involved could be solved. It is one type of dialysis that should be considered for the future. T2 The Kinetics of Daily Hemofiltration A.C. Yamashita Department of Materials Science and Engineering, Shonan Institute of Technology, Kanagawa, Japan Introduction: From our experience in peritoneal dialysis, short, frequent blood purification sessions complement the disadvantage of lower efficiency in removing substances, and have resulted in good Fax 41 61 306 12 34 E-Mail [email protected] www.karger.com © 2004 S. Karger AG, Basel 0253-5068/04/0227-0003$21.00/0 Accessible online at: www.karger.com/bpu Abstracts 3

Transcript of Bpu 22003.qxd - Karger Publishers

Keynote Lecture

K1

Controversies and Issues inHemodiafiltration TherapyN.K. Man

Department of Nephrology – INSERM U 507 HospitalNecker, Paris, France

Hemodiafiltration (HDF) which combines diffusive and convec-

tive methods for solutes mass removal should be the most effective

technique of renal replacement therapy. However, this established

technique had not the foreseen development which it deserved.

Several drawbacks of the therapy which are not counter-balanced by

significant advantages, are identified for discussion. Compared to the

unique simplicity of standard hemodialysis, most of nephrologists are

reluctant to use HDF due to its cumbersome operating mode which,

in addition, requires more stringent maintenance rules. The extracost

of disposable items is also a potent factor in the decision-making.

Although technical advances permit to produce on-line substitution

fluid, the potential risks and hazards associated with the injection of

a contaminated dialysate in the blood stream, do exist. Indeed, pro-

duction of ultrapure dialysis fluid, in which endotoxin and bacteria are

undetectable, relies on the implementation of ultrafilters on the dial-

ysis pathway. However, multiple use of such a sterilizing module

allows the formation of biofilm, where bacteria and endotoxins could

be then, released in the dialysate and infused to the patient. Single use

of ultrafilters is, therefore, mandatory. The availability of high flux

hemofilter and the low cost of substitution fluid produced on-line

leads to the practice of excessive ultrafiltration flow rates, as high as

300 mL/min, where loss of aminoacids and water soluble vitamines,

among other vital substances, should be taken in consideration.

Furthermore, infusion of large amount of dialysate containing resid-

ual acetate of 2–7 mmol/L could lead to long-term complications.

Acetate-free dialysate should be used as substitution fluid in on-line

hemodiafiltration. An alternative to these issues could be the HDF

technique with on-line regeneration of the ultrafiltrate by adsorption

of uremic waste products onto synthetic resin and mineral charcoal.

One of the most promising development of HDF remains in its predi-

lution mode where dilution of blood increases the free moiety of

metabolites bound to proteins, which become available for removal.

Pre-dilution mode HDF should be extended in practice since it seems

to enhance removal of protein-bound uremic toxins. Clinical investi-

gations are then needed to demonstrate the extra-benefits of this tech-

nique. Finally, future extension of HDF to standard application

depends on studies of large cohort of patients regularly treated with

HDF on outcome, in terms of quality of life, morbidity and mortality.

Current Topics

T1

Expectations toward Daily HemofiltrationH. Kawanishi

Tsuchiya General Hospital, Hiroshima, Japan

The result of the HEMO study on whether the increase in dialysis

dose (Kt/V) would improve the survival rate of patients was published

last year. Counter to the expectations, it revealed no difference in the

survival rate, even when the spKt/V was increased to more than 1.25

in HD thrice weekly. The results suggest that dialysis needs to be per-

formed over a longer period of time and more frequently in order to

obtain higher survival rates. Currently, various patterns of daily dial-

ysis are being sought, as seen in the development of an HD device for

home use by Aksys Co. However, a water treatment system is essen-

tial for HD, which is the greatest obstacle for home and continuous

dialysis. On the other hand, if a refilling solution becomes available,

a water treatment device would not be necessary for hemofiltration,

which will make it simple and easy to perform. The Daily HF has

made use of this advantage. Basically one session of Daily HF is 1.5

to 2 hours and is performed 6 times weekly. If the filtration volume

for 1 session is targeted at weekly Kt/V:2.0, it accounts for 40% of the

body fluid volume (V). Because the method is hemofiltration, the

removal of large molecular weight substances is performed more effi-

ciently than the usual HD. According to our experience over a short

period of time, the average removal of urea per unit time was

5.1 mL/min (weekly Kt/V 2.0), and that of � 2 MG was 1.6 mL/min.

What is needed for Daily HF is a bag of refilling solution, a home

delivery system, and an HF device. As these are already on the mar-

ket, it will not be difficult to realize this therapy, if the problem of

medical costs involved could be solved. It is one type of dialysis that

should be considered for the future.

T2

The Kinetics of Daily HemofiltrationA.C. Yamashita

Department of Materials Science and Engineering,Shonan Institute of Technology, Kanagawa, Japan

Introduction: From our experience in peritoneal dialysis, short,

frequent blood purification sessions complement the disadvantage of

lower efficiency in removing substances, and have resulted in good

Fax �41 61 306 12 34

E-Mail [email protected]

www.karger.com

© 2004 S. Karger AG, Basel

0253-5068/04/0227-0003$21.00/0

Accessible online at:

www.karger.com/bpu

Abstracts

3

4 Blood Purif 2004;22(suppl 1):1–30 Debates 1–4

D1-2

The Paramount Role of Peritoneal DialysisJ.C. Divino Filho

Baxter Renal Division Europe

At each point in time during their lives, patients requiring renal

replacement therapy (RRT) should receive the treatment modality,

where possible, that maximize their health outcomes. Preservation of

residual renal function (RRF) has major benefits and is a valid thera-

peutic goal in both PD and HD, which should not be regarded as com-

petitive, but as complimentary therapies. The awareness of the

importance that preserving RRF plays in the clinical outcome of dial-

ysis patients has been expanded in the last few years. Rottenbourg

et al. had already reported in 1982 that RRF was better preserved in

insulin-dependent diabetic patients on CAPD when compared to HD

patients. Several later papers confirmed the evidence that RRF was

better preserved in PD than in HD even though there have been certain

limitations in these reports (for example; retrospective analyses, not

matched for underlying disease or GFR). The benefits of preserving

RRF are several, among them facilitating volume control, providing

endocrine functions, increasing quality of life and reducing mortality.

Moist et al. reported predictors of loss of RRF among new dialysis

patients and prescription of HD was considered as a higher risk factor

than even congestive heart failure or diabetes mellitus. Prospective

studies of prevalent and incident patients have identified the important

role of RRF in the survival of patients who are undergoing PD; the

reanalysis of the CANUSA data indicates that the contribution of RRF

is more important than peritoneal clearance. Moreover, a NECOSAD

analysis presented in the ASN 2002, reported that a higher peritoneal

clearance is not associated with a more favorable survival and that the

risk ratio (RR) of death for each ml/min/1.73 m2 increase in GFR was

0.90 after adjustment for age, co-morbidity, SGA and albumin.

Cardiovascular disease is the major cause of death in dialysis patients,

accounting for well over 40% of their mortality. Hypertension has been

suggested to be one of the strongest risk factors for left ventricular

hypertrophy (LVH) in dialysis patients and its high prevalence sug-

gests that fluid removal is inadequate. Fluid overload itself is also

believed to be a causative factor in the development of LVH/LV dys-

function, independently of blood pressure. PD as initial therapy has

been advocated as it spares vascular access, improves cardio-vascular

stability, enhances life-style flexibility, reduces the incidence of blood-

borne infections and preserves RRF. Among the potential causes of

RRF preservation in PD, the avoidance of dehydration/hypotensive

episodes and the more physiological rate of fluid removal are consid-

ered as important ones. Charytan et al. have reported a significant

higher incidence of hypotensive episodes in patients on HD than

CAPD (15.6 versus 0.46 episodes per patient per year, respectively).

Lang et al. have showed in a prospective investigation (and with both

groups not differing in determinants of renal function) that the better

RRF preservation in CAPD patients corresponded with greater car-

diovascular stability when compared to low and high flux HD. In PD

therapy, when the prescription of icodextrin 7.5% is compared to the

prescription of glucose as osmotic agent, PD patients using icodextrin

achieve better ultrafiltration and fluid balance improve with reduction

in total body water and extracellular water. It is important to observe

that these improvements are accompanied by better maintenance of

RRF. The better preservation of RRF seen with PD patients may also

be translated into an improved likelihood of recovery of renal function

clinical effects. An attempt to perform this by hemofiltration, namely

‘daily hemofiltration (HF)’ has been made recently. We are reporting

on the characteristics of solute removal in daily HF, which we studied

using a kinetic model. Method: A patient receiving hemodialysis

(HD) of 4 hours per session thrice weekly was assumed. The effi-

ciency of solute removal was compared to the efficiency in the ther-

apy of daily 2 hour HF (postdilution, 12 L filtration/session) using the

internal 2-compartment model, assuming that the patient changed the

therapy. Results and Discussions: When the change from HD to

daily HF was made, the Kt/V urea decreased from 1.2 � 3 sessions to

0.33 � 6 sessions and both the pre- and post-treatment values of urea

increased. The weekly average concentration (TAC) increased by

57% for urea and 45% for creatinine. Weekly clearance of � 2 MG

remained unchanged for both therapies, but after the treatment

change, both the pre- and post-treatment values decreased and TAC

decreased by 51%. We found that after the treatment change, about

2 weeks was required for the concentration to stabilize for small mole-

cular solutes and about 3 weeks for � 2 MG. Conclusion: Daily HF

is inferior in removing small molecular solutes but more effective for

removing medium and large molecular substances (such as � 2 MG)

as they are normally removed more efficiently by filtration. How long

it takes until the concentration moves into the new state of stability

differs by solutes, but more than 2 weeks was found to be necessary

until it was clinically assessible.

Debates 1–4

D1-1

Impact for Preservation of Residual RenalFunction: PD or HDF?H. Kawanishi

Tsuchiya General Hospital, Hiroshima, Japan

Residual renal function (RRF) is recognized as a significant factor

influencing morbidity, mortality and quality of life in chronic dialysis

patients. Moreover, RRF has a major impact on outcomes, its preser-

vation is of vital importance. Recently, several studies have been

reported that RRF is better preserved in peritoneal dialysis (PD) than

in hemodialysis (HD) patients. It has been postulated that either the

use of bioincompatible HD membranes and contaminated dialysate or

hypovolemic episodes during HD are responsible for this difference.

Treatment characteristic of on-line hemodiafiltration (HDF) is

complete ultra-pure dilaysate and the highly removal of large molec-

ular substances. Ultra-pure dialysate restrains the occurrence of the

inflammatory cytokines. Also highly removal of large molecules are

conceivable even the possibility that is removing these cytokines.

Furthermore the stability of the blood pressure during dialysis can be

obtained in HDF. There is the possibility that the blood pressure

stability and biocompatibility exert a good influence on RRF in on-line

HDF. The clinical data that proves this opinion is not yet. In future,

large-scale, prospective and control studies to the preserved RRF on

HDF is necessary.

5Blood Purif 2004;22(suppl 1):1–309th Annual Conference of the Japanese

Society for Hemodiafiltration Therapy

in patients with reversible causes of renal failure, as shown by Katz

et al. and Goldstein et al. The benefits of peritoneal dialysis in the preser-

vation and/or recovery of residual renal function are evident, being

recognized even by physicians performing HD. McKane et al. have

recently reported that in hemodialysis patients using high-flux bio-

compatible membranes and ultrapure water, residual renal function

declines at a rate indistinguishable from that in CAPD. An integrated

care approach to improve the end-stage renal failure patient lifetime on

RRT must encompass pre-dialysis preparation, followed by the best

sequence of the therapies, including timely transfer between modali-

ties. The goal of preserving RRF is of utmost importance both in PD

as well as in HD. The challenge for the nephrologist is to use each of

the therapies to its greatest advantage and thus to maximize quality of

care and longevity of RRT. The existing evidence on the preserva-

tion/recovery of RRF, makes PD an important therapeutical option for

end-stage renal failure patients initiating dialysis.

D2-1

Cost Effectiveness of Blood PurificationProcedures in View of Solute RemovalH.-D. Lemke1, D.H. Krieter2

1Membrana Research Obernburg, Germany, 2Nephrology,University Hospital, Montpellier, France

Despite the absence of large controlled clinical trials, on-line

hemodiafiltration (OL-HDF) is regarded as the best extracorporeal renal

replacement therapy available because it combines the most efficient

solute removal over a wide molecular weight range with highest

hygienic standards. It is, however, the most costly form of dialysis ther-

apy since it needs a specific dialysis equipment (machine, high-flux dia-

lyzer, filters, tubing set) for the preparation of a sterile infusion fluid and

ultra-pure dialysate. Compared to standard HD, OL-HDF has demon-

strated positive effects on treatment tolerance with a decreased number

of hypotensive events, lower B2m levels, and a better control of anemia

in end-stage renal disease (ESRD). Compared to high-flux dialysis, the

better removal of small and middle molecular weight solutes does not

result in lower pretreatment plasma concentrations most probably due to

limitations in mass transfer within the body. Nevertheless, recent studies

have shown that OL-HDF has a positive impact on hyperphosphatemia

by lowering phosphate levels in severely hyperphosphatemic patients,

which would imply the possibility to loosen dietary restrictions and to

reduce treatment costs by less phosphate binder intake and shorter treat-

ment times. High-flux HD with high internal filtration may be consid-

ered as a limited-scale OL-HDF without additional hardware, but

concerning solute removal, particularly of larger uremic toxins, OL-

HDF is by far more effective. Initially promising results of high internal

filtration HD on renal anemia have been disproved by a better controlled

clinical trial. This study indicated that, when compared to low-flux cel-

lulosic membranes, a somewhat superior removal of higher-molecular

erythropoiesis-inhibiting proteins is not the main mechanism to improve

anemia control. Against the background of the complex uremic syn-

drome with the multitude of mainly not identified smaller and larger

uremic toxins involved and, compared to the general population, the by

far higher morbidity and mortality of ESRD patients, it seems to be

justified to offer the best dialysis therapy available. At the moment, we

have to assume that this requirement is met by OL-HDF.

D2-2

In-Line Hemodiafiltration by Enhanced Internal Filtration Is a Cost-Effective TreatmentY. Koda

Koda Medical & Dialysis Clinic, Niigata, Japan

In-line hemodiafiltration (HDF) by enhanced internal filtration is

a cost-effective treatment. Yutaka Koda Director of Koda Medical &

Dialysis Clinic Hemodialysis with high-flux membrane can remove

wide-spectrum of uremic toxins from small solutes to large molecu-

lar weight proteins. This is achieved mainly by improved membrane

performance and in part by internal filtration. Internal filtration is a

phenomenon induced by a pressure drop along the length of hollow

fiber dialyzer, occurring in usual high-flux dialysis. To increase con-

vective solute transport further, dialyzer structures, such as fiber

diameter, fiber length, fiber bundle rate and dialysate compartment

resistance, are modified effectively. Thus, dialysis with modified dia-

lyzer promotes significant amount of convection and can be an alter-

native to HDF (in-line HDF). It can not yet be definitely determined

how much fluid is replaced in each clinical treatment session although

experimentally estimated. To fully pull out In-line HDF performance,

higher blood flow rate and higher quality of water are important.

Some evidences have been reported confirming prevented dialysis

complications and improved survival by high-flux dialysis. As in-line

HDF is considered to be an extension of high-flux dialysis, the same

outcomes might be predictable. In many developed countries, health

care cost and reimbursement of therapies are becoming severely

restricted. In-line HDF is a desirable modality of blood purification

for it neither requires high volumes of substitution fluid, series of

filters, nor additional complex machines.

D3-1

On-Line Hemodiafiltration as RoutineTreatment of End-Stage Renal DiseasePatient: A Plea for Pre and Mixed Dilutional ModalitiesB. Canaud, R. Lévesque, D. Krieter, S. Desmeules,L. Chalabi, H. Leray-Moragués

Nephrology & Renal Research and Training Institute& AIDER, Lapeyronie University Hospital, Montpellier, France

On-line hemodiafiltration (OL-HDF) is a well-recognized treat-

ment modality that offers a way of optimizing renal replacement

therapy efficacy of end–stage renal disease (ESRD) patients. By

enhancing the molecular weight spectrum of uremic toxins removed,

the convective clearance of HDF contributes to improve dialysis effi-

cacy. By increasing the instantaneous solute flux of small solutes,

HDF facilitates the restoration of ‘internal milieu’ of ESRD patients.

By improving the hemoincompatibility of the dialysis system (syn-

thetic low-reactive membrane, protein coating, ultrapure dialysate),

HDF reduces long-term side effects of ESRD treatment. On-line

6 Blood Purif 2004;22(suppl 1):1–30 Debates 1–4

production of substitution fluid by ‘cold sterilization’ process

(ultrafiltration) gives access to unlimited amount of sterile and non-

pyrogenic IV grade solution. This advantageous low-cost solution

may be therefore employed to develop various forms of high-flux

HDF modalities. High-flux post-dilutional HDF (post-HDF) has been

mainly used in clinic and most results reported in scientific studies

rely on this modality. The choice of this modality can be easily

explained by the fact that post-HDF offers the best compromise

between diffusive and convective instantaneous clearances for a fil-

tration fraction 20–30% in the same filter. Nowadays, the new targets

in anemia correction (Hb 110–130 g/l, Hematocrit 33–39% predialy-

sis, EBPG and DOQI) have created hemorheological conditions that

render high filtration rate more difficult to achieve and/or at the

expense of higher transmembrane pressure (TMP). To overcome this

new challenging condition and keeping with the same concept, it has

been proposed to develop alternative modalities with various site of

fluid substitution (predilution, mixed pre-post with various percent-

age) in HDF. More recently, it has been introduced a new HDF device

(cocurrent fibers and internal mixing chamber) permitting to perform

mid-dilution HDF. In this presentation, pitfalls of the different

presently available OL-HDF modalities will be discussed and poten-

tial advantages of the new OL-HDF options (pre, mixed and mid-

dilution) will be stressed in order to keep optimal performances to HDF

treatment. On-Line HDF is a multipurpose treatment method that is

employed to improve care and outcomes of ESRD patients. Due to its

versatility, OL-HDF should be considered as a technical platform per-

mitting to personalize and tailor treatment to the patient’ needs.

Modality and site of substituting fluid is clearly one of this option

that has been developed to overcome these new hemorheological

conditions in ESRD patients.

D3-2

Post-Dilution Method Is More Beneficialthan Pre-Dilution in On-LineHemodiafiltrationI. Masakane

Kidney and Dialysis Center, Yabuki Hospital, Yamagata,Japan

In the past two decades, hemodiafiltration (HDF) has been

thought to be the most favorable modality to improve quality of life

and prognosis of patients treated with chronic hemodialysis. There are

various methods to infuse substitution fluid into the blood such as

post-dilution, pre-dilution, combined method (pre-post method) and

push-pull method. Historically post-dilution method has been major

one. On-line preparation of substitution fluid makes it possible to per-

form pre-dilution HDF with large volume substitution apart from eco-

nomical problems. Both post-dilution and pre-dilution methods have

advantages and disadvantage similarly, therefore we should choose

more favorable one for clinical use. However, it has been still contro-

versial which technique is better in on-line HDF. When we choose one

for clinical use, we should select the suitable dialyser membrane and

set proper blood flow rate and substitute flow rate corresponded with

the dilution method. In post-dilution, it is well known that clearances

of small molecular uremic toxins increase as well as low molecular

proteins, however the risk of albumin leakage caused by high trans-

membranous pressure also increase. On the other hand, pre-dilution

method is rather safety in the risk of albumin leakage but has obvious

clearance loss of small molecular substances caused by decreased

dialysate flow rate. In this debate, I’d like to emphasize advantages of

post-dilution method compared with pre-dilution method in various

points of view.

D4-1

Hemodialysis Machines: Individual versus Central Dialysate Preparation. A European ViewT. Roy

Fresenius Medical Care AG, Bad Homburg, Germany

Hemodialysis Machines: Individual versus Central Dialysate

Preparation. An European View Thomas Roy, Ph.D. Fresenius

Medical Care AG, Bad Homburg, Germany. In contrast to Japan, the

configuration of hemodialysis machines as bedside stations, operated

together with a central dialysate supply system, has completely dis-

appeared in Europe since the early years of chronic hemodialysis.

Nearly all HD machines in the field are single patient machines,

which continuously prepare individual dialysate while being supplied

with purified water, concentrates and electricity. The trend towards

single patient machines started in the early years of chronic hemodial-

ysis (1965–1975) when much of the equipment used were indeed bed-

side stations with central supply systems or batch systems preparing

the whole amount of dialysate for a single dialysis treatment in one

single preparation step prior to dialysis. This development was mainly

caused by three different reason: 1. European dialysis doctors always

considered dialysate composition to be an important therapeutical tool

to be prescribed for the individual patient. 2. In the early days of chronic

dialysis home hemodialysis (HHD) played an important role. Conse-

quently there was a need for technical equipment, which could be

operated in centers/clinics as well as in a home environment. These

devices necessarily were single patient machines. 3. The use of central

dialysate supply systems was further discouraged with the

re-introduction of bicarbonate buffered dialysate and the respective

problems related to bacterial contamination of especially the bicar-

bonate pathway. Mainly for reasons of logistics and handling centers

increasingly used central concentrate supply systems for both acid and

bicarbonate concentrate(s) instead of bulky canisters. The bicarbonate

component had to be ultrafiltered prior to mixing. However, this

situation has dramatically changed in favor of dry powder components,

which are dissolved online by the machine. The process started in the

1990ies with dry bicarbonate cartridges or bags and currently continues

towards concentrate supply systems where also the sodium component

comes as sodium chloride powder. These modern supply systems

comprise highly concentrated, low-volume liquid concentrate bags

only for K�, Mg2�, Ca2� and glucose where chemical incompatibili-

ties require separate packing and storage. This technology allows for

highly individual dialysate compositions with a relatively small number

of different formulations for the liquid bag. The use of mostly dry

components offers a variety of advantages concerning therapeutical

flexibility, logistics, handling and ecology. Furthermore, since special

connectors are required for the three different concentrate components,

potentially life-threatening human errors related to concentrate handling

are excluded. Nevertheless, all these sophisticated ways of providing

7Blood Purif 2004;22(suppl 1):1–309th Annual Conference of the Japanese

Society for Hemodiafiltration Therapy

concentrates to the HD machine require a significant technical effort

at the machine side, which always was the major disadvantage of

single patient machines compared to the simple technical layout of

traditional bedside stations. An alternative, increasingly used in various

European countries, is given by the original technique of preparing

the whole amount of dialysate for one single dialysis session in form

of a single batch prior to treatment. A respective device, the Genius®

Therapy System, combines extreme technical simplicity with the

required degree of flexibility in terms of dialysate composition. In its

current configuration, a central unit for batch preparation and post-

treatment machine processing serves about 6–10 dialysis machines.

It is possible to adapt this technology to home use also. The design of

this modern batch system overcomes all major disadvantages of

former batch systems (reduced efficiency due to dialysate recirculation,

practically uncontrollable microbiological growth) while maintaining

the striking technical simplicity of the original devices. In future it

may be required for economical reasons to find other, new ways of

combining the advantages of single patient machines with the advan-

tages of bedside stations. Such configurations will be favorable for

center environments but may not offer significant advantages for

home use.

D4-2

Labor-Saving and Safety Come from theFully Automated Dialysis System of CentralDialysate SupplyH. Kawanishi

Tsuchiya General Hospital, Hiroshima, Japan

The medical cost is key point of dialysis field. Especially, the

mainly part of the cost becomes personnel expenses. On the other

hand, recently the medical quality and safety are requested. It

becomes needed for future dialysis treatment to achieve these both

quality of patients and cost. In our facility, chronic dialysis program

was started from 1967 and used central dialysate supply system with

lower cost of personnel expenses. However, recent change of medical

situation became difficulty to penetrate cost superiority principle. For

corresponding to this situation, we introduced a fully automated dial-

ysis system developed by Dr. Kim and JMS, Co. With this automated

dialysis machine, the reverse filtration dialysate is used for priming,

returning blood and infusion fluid. In the results, the workload of the

dialysis staff seems to have considerably reduced. Furthermore, the

preventing medical accidents and in-hospital infection is obtained. In

the present, the fully automated dialysis system of central dialysate

supply is said as a supreme labor-saving and safety system.

Symposium: Water TreatmentSystem and Clinical Outcomes

SY-1

Ultrapure Dialysis Fluid – Direct and Indirect Benefits in Dialysis TherapyI.L.E. Ledebo

Gambro Corporate Research, Lund, Sweden

The fluid quality description ‘ultrapure’ means practically free

from bacteria and endotoxin. In quantitative terms it is defined as

�0.1 CFU/mL and �0.03 EU/mL. The requirements on endotoxin as

well as bacteria should be fulfilled, because these two entities are not

strictly correlated with each other. Ultrapure dialysis fluid can be pre-

pared from standard quality fluid by a single step of controlled ultra-

filtration. Recent clinical studies demonstrate that the use of ultrapure

dialysis fluid in hemodialysis is associated with patient benefits indi-

cating a less inflammatory state compared to hemodialysis with stan-

dard fluid. Reports show lower CRP values, reduced need for EPO,

better nutritional status, reduced levels of B2-microglobulin, less inci-

dence of Carpal Tunnel Syndrome and even better preservation of

residual renal function. By applying one additional step of controlled

ultrafiltration, ultrapure dialysis fluid can be further purified to such

high microbiological quality that it can be used for infusion. This

opens up the possibility for convective therapies, hemodiafiltration

and hemofiltration, for which large volumes of sterile infusion solu-

tion are needed. With optimal application of these therapies solute

removal is enhanced, qualitatively as well as quantitatively, and fluid

management is facilitated through improved hemodynamic stability.

These benefits can be added to the excellent biocompatibility con-

ferred by the high-quality fluids and the use of synthetic, biocompat-

ible, high-flux membranes. The direct impact on survival of improved

fluid quality can not be seen as an isolated phenomenon, because

ultrapure dialysis fluid is most often used in combination with bio-

compatible, high-flux membranes and often in convective therapies.

Evidence for a significant survival benefit with these applications is

still lacking, but a number of observational studies indicate reduced

mortality risk. Conclusions: There are direct as well as indirect

clinical benefits from using ultrapure fluids in dialysis. The direct

benefits are a consequence of reduced inflammatory stimulus.

Indirect benefits are connected with the further purification into ster-

ile, non-pyrogenic fluid and using this fluid as substitution solution in

hemodiafiltration and hemofiltration. These therapies provide

enhanced solute removal and hemodynamic stability in addition to the

benefits of superior biocompatibility.

8 Blood Purif 2004;22(suppl 1):1–30 Symposium: Water Treatment System and

Clinical Outcomes

SY-2

Dialysate Purification for Large-VolumeHemodiafiltrationM. Goto

JMS, Co., Ltd, Hiroshima, Japan

Treatment environment surrounding patients needing hemodialy-

sis has deteriorated over the last several years, due to the aging and

the prolonged period of treatments of many patients, and the rise in

incidence of diabetes and other complications. Under such circum-

stances, efforts are being made by treatment facilities to develop new

procedures and devices to improve the QOL of the patients. Large-

volume hemodiafiltration (HDF) and Internal Filtration Enhanced

Hemodialysis (IFEHD) are now more readily available, improving

treatment efficacy, in particular, of patients with adverse conditions.

These new methods allow a larger volume of fluid flow in the body –

which however raises the quality requirements for dialysate. JMS

introduced the dialysate purification procedure 10 years ago. We con-

trol the entire flow of fluid from the RO system to the terminal dialy-

sis console. We can provide ultra pure dialysate on a constant basis.

What is really crucial is the degree of purity of the fluid at the RO

apparatus, which is located at the extreme upstream. Irrespective of

any contamination or change in the quality of water at the source,

dialysate must be clean and free completely of endotoxin, and also the

supply of the fluid must be stable and abundant. In the downstream of

the RO apparatus, it is crucial that design of the entire system and the

entire piping assures the following 3 conditions: (1) there is no stag-

nant water or any water retention, (2) a fluid flow over a predeter-

mined velocity is attained (through loop piping etc.), and (3) it is

possible to clean all the lines including those within the system. Many

reports are coming in from treatment facilities on the positive clinical

contribution of the dialysate purification to the QOL of patients.

There will be higher needs in the future for administering over a pro-

longed and extended period of time of large-volume replacement type

HDF systems including on-line, push-pull as well as IFEHD. As a

consequence, there is an ever greater requirement for a system, which

facilitates the dialysate purification relatively easily, and assures a

stable supply of the fluid for an extended period of time.

SY-3

Dialysate Purification System by NiproT. Sunohara, T. Masuda

Research & Development Laboratory, NIPRO Co., Osaka, Japan

We are receiving reports of clinical improvements made possible

by the dialysate purification. Hence, the need for a better purification

system is ever greater. Described below is a high-quality dialysate

purification system developed by Nipro. Dialysate being a pharma-

ceutical product, we believe it should have the same quality level as

a parenteral solution. Ideally, the manufacturing facility for dialysate

should have the same process and equipment as that for making

pharmaceutical-quality water. The biggest difference between the

conventional dialysate production process and the pharmaceutical

water production process is that the latter includes distillation and

high-temperature circulation steps, both of which help inhibit bacterial

propagation. On the other hand, it is not realistic to incorporate distil-

lation or a high-temperature treatment into the dialysis process. Now

many dialysis facilities are equipped with UF membrane and RO

membrane filters to produce pyrogen-free water. For inhibiting bacterial

growth, Nipro proposed a parallel single path (PSP) piping system to

supply clean dialysate relatively easily. The PSP system employs a

single path process. Also, we use a pipe material which prevents

sediment depositing to assure a constant flow velocity, thereby

preventing any secondary contamination of dialysate. In addition to

the construction of the contamination-free piping, we provide an

endotoxin cut filter and a low-contamination risk coupler at the end

of the dialysate line to reduce endotoxin risks. The hollow fiber

membrane of the endotoxin filter is rated for differentiating mole-

cules at a molecular weight of 6,000, i.e. the same quality as for

medical injection. The hydrophobic polyether sulphone material has

strong adhesion and differentiation characteristics to maintain the

exdotoxin level at below detectable limits. In order to further raise the

reliability of dialysate purification, it is ideal to monitor the endotoxin

level at the downstream end of the dialysate line. The conventional

method for endotoxin monitor is troublesome and time consuming in

the sampling and measurement processes. So we have developed a

continuous endotoxin monitoring system based on the surface

plasmon resonance. The sensitivity of this monitoring system is at the

level of 1 EU/L, and it is also possible to link the monitor to a dialyzer.

SY-4

Purification of DialysateM. Takahashi

Medical Equipment Unit, NIKKISO Co., Ltd, Tokyo, Japan

The use of high-performance dialyzers becoming the mainstream

in hemodialysis, dialysate purification is now a crucial issue. It is

extremely important to make sure that a Hemodialysis System does

not become the source of dialysate contamination. Our company has

taken measures and has made improvements to Hemodialysis System

to assure the purity of dialysate, as described below.

1. Dialyzer coupling (Clean Coupling DLJ-01) makes possible

automatic cleaning and automatic disinfection of its O-rings portion.

2. New microparticle filter (EF-02) can be connected to the holder

with smooth stream surface, not having an O-ring.

3. Concentrate nozzle can be cleaned and disinfected automatically

by cleaning unit.

4. Solenoid valves employ the diaphragm system. The manifold

structure which consists of 2 solenoid valves and a fluid pressure

sensor reduces pipe junctions.

5. Chambers adopted shapes which prevent fluid detention.

6. Pressure reducing valve is integrated with relief valve to form a

structure without any space for drain retention.

7. Stainless steel joints processed by cutting were replaced by

molded plastic to allow for smoother fluid pass.

8. Recyclic cleaning and disinfecting system for the deaeration circuits.

We will continue develop hemodialysis systems which will con-

tribute to dialysate purification, which in turn will raise the QOL of

the patients undergoing dialysis.

9Blood Purif 2004;22(suppl 1):1–309th Annual Conference of the Japanese

Society for Hemodiafiltration Therapy

SY-5

Total Purification SystemA. Sugimoto

Renal Care Business Division, Toray Medical Co., Ltd, Tokyo, Japan

Objective: There is a wide recognition that securing a highly

clean level at the upstream, namely that of the RO water, is the key to

maintaining the purity of dialysate. Stagnation of the RO water causes

the ET count to rise. This is often due to live bacteria residing in the

RO water, which is usually not disinfected routinely. (For instance, live

bacteria often reside in ultra pure water used for industrial purposes

which may be disinfected weekly.) A hemodialysis line is washed by

the RO water after disinfection. So, a similar bacterial contamination

may occur in such an environment. So we should assume that ‘live

bacteria are always there.’ Sometimes a chemical solution of high

density is kept within the system for overnight for disinfection. However,

there is a danger of a residual chemical. Also, a high-concentration

solution tends to corrode metal and resin surfaces, which in turn

produces cavities where bacteria may create colonies. So, we exam-

ined effective methods for maintaining the cleanliness of the dialysis

system as a whole after use. Method of Study: Microbial organisms

which reside within the RO water are aquatic bacteria (oligotrophic

bacteria). We found that an extremely low concentration of sodium

hypochlorite sufficiently controlled proliferation of such bacteria. We

devised an automatic system, therefore, to inject sodium hypochlorite

just downstream of the RO membrane in the RO apparatus so that a tap

water-level low concentration sodium hypochlorite solution fills the

system overnight. We also made an arrangement to fill the low-

concentration sodium hypochlorite solution from the RO water piping

up to the system in the case of single-patient machines where such

machines tend to have a substantial waiting period between uses. We

also incorporated an adjusting mechanism to the central apparatus so

that after a high concentration chemical is used for disinfecting, a low-

concentration solution may be provided for being kept within the

system overnight. Results: Filling the dialysis system routinely with

an extremely low-concentration sodium hypochlorite solution made

the maintenance of the ET counts of the RO water downstream of the

RO membrane to the downstream end at a constant low level for a long

period of time. On the other hand, the live bacterial counts in the case

of single-patient dialysis machines differed depending on whether

injecting of disinfecting solution was incorporated or not.

Conclusions: The prevention of contamination is certainly more

important than taking measures after contamination. The purification

of dialysate should be tackled as a system as a whole, namely, by

strengthening the cleanliness of the upstream where there is usually no

routine disinfection. This will contribute to the consistent maintenance

of the dialysate purity without causing undue burden to medical staff

members.

SY-6

Impact of Dialysate Purification on Chronic InflammationK. Arizono1, K. Nomura1, T. Motoyama1, Y. Matsushita1,K. Matsuoka1, H. Fukui1, H. Takeshita2, R. Miyazu3

1Department of Nephrology, 2Laboratory Department,3Kumamoto Chuo Hospital Ushibuka City Hospital,Kumamoto, Japan

Objective: To study the impact of dialysate purification on

chronic inflammation, by using a highly sensitive CRP. Patients/Subjects and Method of Investigation: Our dialysis treatment

facilities underwent renovation and a dialysate purification system

was introduced as part of the renovation. As a result, endotoxin level

at the downstream end declined from 70 EU/L to below 1 EU/L. We

conducted a comparative study on 23 maintenance hemodialysis

patients prior to the renovation, and approximately over one year after

the introduction of the dialysate purification. The average age of the

patients was 63(�13) and the average number of years of dialysis

treatment was 4.4(�6.1). Our analysis covered: highly sensitive CRP

levels, conditions of anemia, � 2-m and albumin values. Results:The comparison of medians of highly sensitive CRP levels showed a

statistically significant decline after the dialysate purification. The

� 2-m values started to decline significantly after 4 months. Hb val-

ues improved significantly at the 6th, 11th and 12th month after

the introduction of the dialysate purification although the rHEpo dose

remained the same. The albumin values are also improving.

Conclusions: By purifying and making the dialysate endotoxin-free,

the conditions of patients made substantial improvements in highly

sensitive CRP, Hb, � 2-m and albumin values. We also found that the

endotoxin level of 70 EU/L in dialysate may likely lead to chronic

inflammation, and that the dialysate purification is essential as a

measure against chronic inflammation.

SY-7

Importance of Water Treatment System inDialysate Purification and Clinical EffectsN. Suzue, K. Kawahara, T. Mizuguchi, J. Minaguchi,S. Kawashima

Kawashima Hospital, Tokushima, Japan

Objective: The reduction of endotoxin in dialysate to a level

below detectable limits, which is achieved by dialysate purification, is

found to delay the occurrence of dialysis amyloidosis, also contribut-

ing to the improved nutritional conditions and hemodynamics of

patients during dialysis. At the same time, chronic contamination of

dialysate even if slight is widely recognized to lead to complications

associated with hemodialysis. Apart from the endotoxin removal of

dialysate by endotoxin cut filters, we have now introduced a new sys-

tem to reduce endotoxin concentration in the process of manufactur-

ing water to be used for diluting dialysate. This is a report of clinical

effects brought out by the change of dialysis system. Patients/Subjects: We examined 25 maintenance hemodialysis patients, who

continued to receive the same dialysis treatments after the system

10 Blood Purif 2004;22(suppl 1):1–30 Educational Lectures

change. Method of Study: We made comparison of the levels of

dialysate purity, as well as immune responses, hematopoietic func-

tions and nutritional conditions of the patients prior to, and respec-

tively 6 months, 12 months, 18 months and 24 months after the

system renovation. Results: Although the change in detected endo-

toxin concentration at the downstream of dialysate as a result of

the introduction of dialysate purification was slight, both the highly

sensitive CRP and highly sensitive IL-6 values recorded a significant

decline. The hematocrit values also made a significant improvement.

Conclusion: The use of endotoxin cut filters is not sufficient to

attain a high purification level of dialysate. It is essential that endo-

toxin removal be rigorously implemented starting at the process of

manufacturing water to be used to dilute dialysate.

Educational Lectures

EL-1

‘Water Treatment – Fifteen Years ofExperience at Our Hospital’ and TroubleShootingT. Takamiya, K. Imamura

Takamiya Hospital, Kumamoto, Japan

In 1990, when our hospital was rebuilt, data on the number of bac-

teria, endotoxin, etc. were collected from the external water tanks, pip-

ings and RO membranes over a period of more than 1 year, and found

that the dialysis solution remained stable without seasonal fluctuation.

We therefore performed P/P HDF and found improvements in the

patients’ symptoms. Then we devised the current central type on-line

HDF, and started performing on-line HDF utilizing the dialysis solu-

tion. Currently we have returned to our initial state and are performing

HD using cleaned dialysate, and have seen improvements in conditions.

The tracing of the effects is going on. We will report on the process and

results of trial and error on water treatment in our hospital, and how we

got to the present state, as well as the details of trouble shooting.

EL-2

The Blood Flow Rate and the Dialysate Flow RateK. Sakurai

Hashimoto Clinic, Kanagawa, Japan

Standard dialysis is performed at QB200 mL/min and

QD500 mL/min, but for HDF, particularly on-line HDF, there is no

consensus as to where the total dialysate flow rate should be kept, how

low the QD should be brought down to and how high the QF should be

brought up to. In the usual PS membrane dialyzer, a dialysate flow

rate of more than 300 mL/min is required to remove low molecular

substances with good efficiency. Therefore a replacement solution

flow rate of more than 220 mL/min (50 L, 4 hours dialysis) is required

for removing low molecular proteins to some amount. If the total

dialysate flow rate is raised to 600 or 700 mL/min, it is quite evident

that an efficient on-line HDF can be performed, but the current finan-

cial environment of dialysis does not allow it. By changing the blood

flow rate and dialysate flow rate, we have examined what flow rates

constitute an efficient dialysis, primarily in on-line HDF (predilu-

tion). Items examined were Kt/V, removal rate (BUN, Creat, � 2 MG,

� 1-MG), clearance (value at 1 hour for the same items given in the

removal rate), clear space (the same items as in the removal rate), and

leakage of Alb. These were examined with QB200 mL/min as the ref-

erence level for the change in blood flow rate and QD500 mL/min as

the reference level for the change in dialysate flow rate. The subjects

were 7 stable patients on long term dialysis (one 90 kg in body weight,

five between 50 and 60 kgs, and one 45 kg). Also, when the blood

flow rate was raised from 220 mL to 300 mL while the dialysate was

kept constant in NK-PS18S-21S and FDY-18GW-21GW and the items

examined, interesting results were obtained.

EL-3

Optimal Values in Replacement of Body FluidM. Miwa

Nagoya University Hospital, Nagoya, Japan

We will re-evaluate the blood purification therapy using Kt/V for

urea as index for the efficiency of removing small molecules and

Kt/V for � 2-microglobulin as index for efficiency of removing low

molecular weight protein. The uniform optimal value of Kt/V for urea

(1.2–1.6) used traditionally can be applied to average dialysis patients,

but should not be applied to patients who have values in their data that

divert greatly from the standard value. The hemodiafiltration, which

has high Kt/V for � 2-microglobulin, not only reduces the risk

of aggravating dialytic amyloidosis but also improves the patient’s

life expectancy. The optimal Kt/V value for urea for patients on

hemodialysis can be applied to patients on hemodiafiltration.

EL-4

Care of Vascular Access and TroubleShootingT. Chiba

Yokohama Dai-ichi Hospital, Yokohama, Japan

Vascular access, the inlet and outlet of blood, is indispensable if

blood purification is performed in an extracorporeal circuit. However,

making and repairing vascular access is becoming difficult with the

increase in patients who are aged, diabetic, or on long term dialysis.

Some patients have to use artificial blood vessels even for the initial

vascular access. In the 1,693 cases of vascular access surgery over the

past 5 years at our hospital, the number of re-construction or repair

11Blood Purif 2004;22(suppl 1):1–309th Annual Conference of the Japanese

Society for Hemodiafiltration Therapy

cases was 1,440, including referrals from other facilities, accounting

for 85% of the total cases. Cases where artificial blood vessels were

used numbered 97, showing a rise. There were also quite a number of

cases in which the shunt was closed after the artery was accessed, due

to complications such as peripheral circulatory failure or heart failure.

Most of the troubles were caused by stenosis of the shunt vein, and over

the past 1 or 2 years, the number of cases of intervention to improve

this has increased rapidly. Securing optimal vascular access for each

individual patient will have good affect even on the patient’s life

expectancy. The technicians, or the makers should be well versed in

how vascular access is used in the actual setting, while the staff, who

are the users, should always observe carefully to detect troubles early

and provide care in their routine bedside work. Getting a chance to see

first hand the way they are made or repaired may be helpful. We will

report on what kind of troubles are seen in the vascular access, and how

to make judgments in emergent situations and handle the problem.

Seminars 1–6

S1-1

The Economic Effect of Using HDFK. Tsuchida, Y. Takemoto

Department of Urology and Division of Artificial Kidney,Osaka City University Graduate School of Medicine,Osaka, Japan

The HDF/HF and especially the on-line HDF/HF is one of the

breakthroughs at the present point for conditions such as renal anemia,

dialysis-related amyloidosis, dialysis-associated hypotension, pruritus

cutaneous, which have remained unaddressed as untreatable because

of the difficulty in substance removal and water treatment. It also sug-

gests the possibility of improving the prognosis of patients with end-

stage renal failure. However, to perform and continue on-line HDF/HF

is very costly requiring investment on equipments for water treatment,

supplies such as endotoxin cutting filters, a circuit exclusively for the

replacement fluid, a water quality control monitor, measuring devices,

high water permeability membranes, etc. In addition, as it is not listed

in the National Health Insurance Scheme for reimbursement, there are

many facilities that do not perform this even though they desire to do

so. By thoroughly purifying the water, and with the use of fully auto-

mated consoles, personnel costs can be reduced, and by overcoming

anemia and other complications, and with the improvement of prog-

nosis, it is likely to be an advantage from the standpoint of health eco-

nomics in the long run. In this seminar we will analyze the practical

costs involved in implementing on-line HDF/HF and examine its use-

fulness from the standpoint of health economics, with simulations and

discussions on clinical effects.

S1-2

Radical Stress and HDFT. Tomo

Second Department of Internal Medicine,Oita University, Oita, Japan

The involvement of radical stress has been suggested as cause for

complications in patients on dialysis, such as arterialsclerosis, dialysis-

related amyloidosis, etc. It has been reported that the increase in rad-

ical stress is not only seen in renal failure; but that its amplified effect

is also seen in the process of blood purification. Our group has

reported on the radical stress reducing effect of HDF. We performed

four types of blood purification (HD, on-line HDF: Pre, on-line HDF:

post, P/P HDF) in patients on maintenance dialysis using the polysul-

fone (APS) dialyzer. The change in radical related markers such as

Pentosidine (total, free) and CML (total, free), and the CTL/Cr ratio,

and the hydroperoxide radicals were studied. In HDF (post, pre), the

amplification rate of hydroperoxide radicals was significantly low,

whereas the reduction rate of CTL/Cr ratio as index for hydroxy rad-

icals was significantly higher in on-line HDF than in HD. Both the

total CML and T-pentosidine increased in HD but showed decrease

in HDF. As HDF uses mass amounts of replacement solution, the

following effects can be expected.

• Suppression of the amplification of hydroperoxide radicals and

suppression of the amplification of hydroxy radicals.

• Suppression of fat oxidation by AGEs themselves.

These anti-radical-stress effects are presumed to be exerted by

effective removal of radical carrier protein, denatured protein, and

complement protein in HDF, by dilution of radicals by massive use of

replacement solution, and by the sequential reduction of the excita-

tion and amplification effects. Blood purification more suitable to the

living body is likely to be realized by HDF.

S2-1

The Ideal State of RO Device and LineMaintenanceS. Takesawa

Suzuka University of Medical Science, Mie, Japan

The Power of Biofilms: When we studied the pipings of a facility

that replaced their RO device and pipings recently, we found quite

thick biofilms built up through all parts of the pipes. The pipes were

made of hard vynil chloride and had many elbows (L-shaped

junctures) and T tubes (T-shaped junctures). It was a surprise that

biofilms built up despite frequent rinsing and cleaning with

hypochlorous acid, acetic acid and other cleaning agents. The film

was quite solid and it was very difficult to rip them off. It seemed

impossible to remove the biofilms once they build up. The Ideal State

of RO Devices: Current RO devices should have no leakage in the

primary side over a period of a few years and the ET concentration

should always be maintained at a one digit level without the ET

cutting filters. For that to be attained, the point is to find out what

pattern of pressure is affecting the RO module, and whether it is

programmed so that the bacteria does not easily proliferate during the

12 Blood Purif 2004;22(suppl 1):1–30 Seminars 1–6

night when it is stopped. Cleaning the Line: There is no method at

present of controlling the building of biofilms without leaving any

residuals of the cleaning agent present, and at low cost. It may rather

be more secure to replace the pipes every year. However, even if

the pipes are replaced, the juncture with the fluid part in the console

cannot be replaced, so it does not serve as the ultimate measure.

A method that can be performed easily and inexpensively at facilities

needs to be established without delay.

S2-2

The Key to Clean Dialysate: A Report from a Clinical ViewpointT. Shinoda

Dialysis Center, Social Insurance Chuo General Hospital, Tokyo, Japan

At the consensus conference of the 46th Annual Conference of the

Japanese Society for Dialysis Therapy (2001), the maximum tolerable

value of endotoxin (ET) concentration in peripheral dialysate was set

at below 50 EU/L and the target value at 10 EU/L. However, it is often

difficult to achieve these values with existing water treatment devices

unless ET cutting filters are used. When a new water treatment device

is being installed, how the RO device is operated and how the RO tank

and pipes of the line are managed is the key to clean dialysate. If an

existing water treatment device is being used, because of restrictions

by structure such as the pipings, the maintenance of the RO device

and the cleaning and sterilization of the line is the key to clean

dialysate. Small scale improvements in piping and modifications in

the cleaning and sterilizing methods of the line can reduce the ET

level. In this seminar we will make proposals for a clean dialysate

referring to the performances in our facility.

S3-1

Whether the Residual Renal Functions CanBe Preserved by HDF and Why They ShouldBe PreservedT. Kuno

Nihon University Hospital, Tokyo, Japan

In the treatment of renal failure in the preserving stage, a strong

motivation works for avoiding the introduction of dialysis or for

delaying it. The attending physician, the patient and the family are all

strongly inclined to preserve the renal function. However, once the

treatment of dialysis is initiated, the concern for preserving the func-

tion declines and becomes neglected. Essentially, patients with renal

failure should receive a consistent treatment from the function pre-

serving stage to the period of dialysis initiation and through the main-

tenance dialysis period, and preserving the residual renal function is

important even after dialysis is introduced. This perception has been

present in CAPD since quite a long time ago, but in the therapy of

hemodialysis, the perception of this as an issue has been lacking. This

was because it was long believed that CAPD had advantage over

hemodialysis in preserving the residual renal function. However, as it

is well know, McKane W et al. in UK published Identical decline ofresidual renal function in high flux biocompatible hemodialysis andCAPD in KI in 2002, through which the issue of preserving residual

renal function in hemodialysis came to be highlighted. In this lun-

cheon seminar, we will focus on ‘preserving residual renal function’

and have discussions with the participants on the floor to find out

what contributions HDF can make in this regard.

S3-2

How Long Can the Residual Renal Function Be PreservedN. Koutoku

Mitajiri Hospital, Yamaguchi, Japan

If the residual renal function (RRF) can be preserved for along

time in patients on maintenance hemodialysis, the quality of life of

patients can remain in a good state and the onset of complications can

be delayed. It is well known that patients on peritoneal dialysis can

preserve their RRF for a longer time than patients on hemodialysis.

This fact suggests that RRF may be preserved by preventing dehy-

dration and reducing harmful reaction caused by hemodialysis. In our

hospital, we perform on-line HDF in principle to all of the patients on

an active life, and also to all of the patients who need to start mainte-

nance hemodialysis. We often measure the IVC and LVDd at any

time, and for patients with no congestion and whose urinary volume

is maintained, we try to preserve the RRF without removing water

unless congestion occurs. Of course we use diuretics in case of need.

There are many cases in which the urinary volume is maintained even

when they fall into ESRF, even if pulmonary congestions are present,

there are cases in which the urinary volume recovers by performing

adequate procedures. How long can RRF (urinary volume) be pre-

served? Is HDF contributing to preserving RRF? We examined 43

patients who had no infection at the starting hemodialysis out of the

total patients who were introduced to HDF. And we compared the 18

patients who were able to preserve their perfect RRF and did not need

the removal of water for more than 1 year (cases of no water removal),

and 25 patients whose RRF reduced within 1 year and water removal

was needed (case of water removal). The duration of the perfect RRF

preserved was 31.33 � 15.98 months for the cases of no water

removal , and 0.71 � 1.5 months for the cases of water removal. I

would like to show the characteristics of the patients in their starting

period, who have the possibility of preserving their RRF for a long

time, and their data obtained 1 year after. And I would like to refer

also to techniques for preserving RRF of ESRF patients.

13Blood Purif 2004;22(suppl 1):1–309th Annual Conference of the Japanese

Society for Hemodiafiltration Therapy

S4-1

The Preparation of Ultrapure Dialysate – The Clinical Usefullness and Its Near FutureT. Sato1, A. Kurosawa1, T. Kurihara2, T. Kurosawa1

1Department of Nephrology and Dialysis, Sumiyoshi Clinic Hospital, 2Dialysis Center, Sumiyoshi Clinic Hospital Fuzoku Oomiya Clinic, Ibaraki, Japan

Discussions on preparing the ultrapure dialysate took place in

Japan presupposing the implementation of on-line hemodiafiltration

(HDF), on-line hemofiltration (HF) and push and pull HDF. In 1994,

the water quality standard of dialysate and substitution fluid for

on-line HDF was established by the Kyushu society for HDF. On the

other hand, with the widely spread of high flux membrane (High

Performance Membrane: HPM) which is more biocompatible to the

body and more capable in removing middle molecular substances, the

phenomena of reverse filtration and reverse diffusion became evident,

and purification of the dialysate has become essential even for usual

hemodialysis (HD) treatment. By developing an environment where

constant supply of ultrapure dialysate is available for dialysis, new

blood purification methods can be performed, such as the internal fil-

tration enhanced HD, on-line HDF, on-line HF that use ultrapure

dialysate as replacement solution. As a result, various clinical effects

have been reported, such as improvement in anemia or nutritional sta-

tus, reduction in � 2-MG levels, and improvement in chronic inflam-

matory reactions. Suppression of complications involving long term

dialysis such as dialysis related amyloidosis and arteriosclerosis is

expected, and even the prolongation of life expectancy. By using

ultrapure dialysate as substitution fluid for saline solution, and apply-

ing the phenomenon of reverse filtration, a fully automated dialysis

machine has been developed, which performs automatic priming,

automatic solution replacement when blood pressure becomes low,

and automatic blood drawing and returning. This may enhance the

safety of the treatment and reduce the medical costs. Furthermore, if

RO devices for personal use can be developed and fully automated

consoles can be made smaller in size and easier to operate, they will

contribute to the wide spread use of home hemodialysis.

S4-2

The Short Term Outlook of HDF TherapyM. Mineshima

Department of Blood Purification, Kidney Center, TokyoWomen’s Medical University, Tokyo, Japan

The number of patients on HDF, a therapy that was included in the

National Health Insurance listing for reimbursement in 1997, has

been increasing steadily. Currently about 10 thousand patients are

receiving the therapy, but the ratio to the total number of patients with

renal failure remains flat at 4.5%. Hemodialysis of the internal filtra-

tion promoting type, where cleaning the dialysate is presupposed, is

receiving attention, but because of the change in the design of the dia-

lyzer in this therapy, an internal filtration exceeding 5 liters in 4 hours

takes place. In this sense, it should essentially be considered as one of

the HDF therapies. On the other hand, in Type II dialyzer currently

used, even in those of high water permeability, an internal filtration

exceeding 5 liters in 4 hours is observed, and the possibility of endo-

toxin contamination due to reverse filtration of the dialysate is

becoming evident. In order to secure safety for the patients, facility

standards for cleaning the dialysate needs to be established, and along

with that, a clear separation of therapies between HD and HDF needs

to be established. As a new blood purification method for hemodial-

ysis of the filtration type, a possibility of an HF which uses the fil-

tered solution derived from the patient’s plasma fluid has been

suggested, and the development of a new system utilizing tubular

cells and membrane distilling technologies is expected.

S5-1

HDF is Superior to PD in Dialysis for the ElderlyI. Masakane

Kidney and Dialysis Center, Yabuki Hospital, Yamagata,Japan

The average age of patients on maintenance dialysis is 62 in Japan

and more than 40% of them are elderly patients above 65. It is widely

known that as more than half of the patients being introduced to dial-

ysis is over 65 years old, chronic hemodialysis patients have become

elder year by year. When we would select a modality of dialysis for

the elderly, it is important to improve QOL, not to discontinue their

lifestyle until then, or to have them start their second life on dialysis

in good spirits.

The following points should be noted in selecting therapies for the

elderly.

1. Hospitalization period should be minimized and the procedures

should be performed speedily.

2. Treatment leading to no or very little complication should be

selected as well as treatment requiring less re-hospitalizations.

3. Treatment where the complications assumed are not directly

linked to endangering the patient’s life should be selected.

4. Treatment of an acceptable standard should be provided to any

type of patient.

5. Therapy that would not excessively change the patient’s lifestyle

and would enable the patient to preserve his or her family ties

should be given.

At the upcoming debate, I would like to present my personal

views regarding the points above and would like to stress the advan-

tage of HD(F) in dialysis for the elderly, referring to some cases

I encountered as well as some literature. As this is a debate with

Dr. Hiramatsu, who is the forerunner of peritoneal dialysis for the

elderly, I find myself trembling with excitement but working with

composure on strategies to challenge him.

14 Blood Purif 2004;22(suppl 1):1–30 Industrial Speeches

S5-2

Is PD Superior to HD(F) in Dialysis for the Elderly?M. Hiramatsu

Department of Nephrology and Medicine Okayama,Saiseikai General Hospital, Okayama, Japan

Hemodialysis and hemodiafiltration, which are renal function

replacement therapies for patients with end-stage renal failure, are

methods for purifying blood with extracorporeal circuits, whereas

peritoneal dialysis (PD) aims at removing uremic substances utilizing

a membrane in the living body, namely, peritoneum. The first cause of

death in patients on dialysis is complications of the heart and circula-

tory diseases. The merit of peritoneal dialysis is that it has less load

on the heart and circulatory organs. It is in the elderly where the mer-

its of this PD can be most utilized. PD is more suitable for the elderly

because of the following physical reasons: vascular access for extra-

corporeal circulation is not necessary; there is little fluctuation in

blood pressure; the internal environment is kept constant; it is easier

to preserve the residual renal function. The merits of PD in the men-

tal and social aspect is that it is believing in the residual abilities of

the elderly and perceiving ‘the dialysis life positively as a special style

of life of the elderly, in which dignity in life and death can be

expected, and is considered to be an advantage over HD(F)’.

S6-1

Prescribing Dialysate and Refilling Solution in On-Line TherapiesT. Tomo

Second Department of Internal Medicine, Oita University, Oita, Japan

As the refilling solution for on-line HDF is not sold on the mar-

ket, cleaned dialysate is used for refilling. Is there any problem

involved in reusing dialysate as refilling solution in on-line HDF? We

compared the components (electrolytes, Na, K, Cl, Ca, and HCO3�,

pH) of the dialysate and the dialysate with the refilling solution in

various modes of HD and HDF (on-line predilution, on-line postdilu-

tion, P/P HDF) as well as blood data from subjects who received HD

and HDF. The results showed that there was no significant difference

in the blood data of patients between the time they received HD and

the time they received HDF. In subjects who shifted to HDF, there was

no tendency of the blood data being excessively corrected from the

data at the time of HD. The current dialysate was found to be useful

as replacement solution in HDF. In addition we will report on points

to note when dialysate is used as refilling solution in on-line HDF.

Industrial Speeches

IS-1

An Effort for Home CareS. Higaki

Renal Division, Baxter Ltd, Tokyo, Japan

Since glass containers for infusion products were launched in

1931, Baxter Limited has developed important therapies that are

indispensable for protecting life, such as artificial kidneys, artificial

lungs, and factor VIII preparations, and has continued to provide

these products in more than 110 countries around the world. It should

be noted that we were the first in the world to manufacture CAPD as

a product. In Japan, the company has evolved along with the devel-

opment of dialysis in Japan, such as the introduction of the artificial

kidney in 1969 and CAPD in 1982. As a pioneer in home care, we

have considered that expanding these therapies is essential to the

development of medical care, and have been engaged in developing

and providing services in CAPD related products in our dialysis

product division. With the principle that in home care, it is not

only the product that is important, but also the service that enables a

safe and pleasant treatment, we have a call center for our products

operating 24 hours a day, a delivery service of dialysate by full-

time delivery officials, supporting systems for business trips and

pleasure travels making use of our network in and out of the country,

and swift response in times of disasters. As the population being

introduced to dialysis is aging, the need for peritoneal dialysis, which

is continuous and has less burden on the circulatory system, and the

need for home care, by which time spent with the family can be

secured, are projected to increase. To address these needs, it is not

only important to continue developing products, but also to continue

providing assistance and up-to-date information. With the spread in

peritoneal dialysis, we will make efforts to contribute to the estab-

lishment of a business model of home care, which can render support

to healthcare.

IS-2

Developing Products Aiming at OptimalDialysisK. Kushiyama

Department of Dialysis Business Development, JMS Co.,Ltd, Hiroshima, Japan

The performance of hemodialysis in Japan is of the highest inter-

national standards due to the constant efforts of comedical staff, such

as the dialysis physicians, nurses, and clinical engineers over a long

period of time. However, recently various issues are emerging: the

regulatory factor of medical cost containment by the Ministry of

Health and Welfare in addition to negative factors on the patient’s

side such as the aging society, the increase in patients on long term

15Blood Purif 2004;22(suppl 1):1–309th Annual Conference of the Japanese

Society for Hemodiafiltration Therapy

dialysis, sharp increase in complications such as diabetes. Our pri-

mary corporate principle is to cope with these issues working together

with people involved in dialysis and try to find solutions. We have

actually pursued this in developing and improving products. As part

of this effort, we have promoted dialysate cleaning since 10 years ago

and have realized an ET free state in the flow from the RO device to

the end of the dialysis console. It should be noted that in the upstream

side of the RO device, achieving an ET value lower than the measur-

able level led to the reduction of secondary contamination risks and

enabled a major reduction in the running cost. Results of studies on

the clinical effect of dialysate cleaning is being published from many

facilities every year, and it is becoming evident that the spread in the

use of cleaning techniques leads to the improvement of the patient’s

QOL. By the use of ultra-pure water for dialysis that can be supplied

inexpensively and stably, our goals are now 1. automation with the

aim at safety, effectiveness, and energy efficiency and 2. provision of

adequate HDF that meets the situation of each individual patient. We

will make efforts so that in the near future, many patients would be

able to receive this therapy and lead a more pleasant life.

IS-3

The Progress of Fresenius Medical CareJapan K.K.Y. Nakano

Fresenius Medical Care Japan K.K., Tokyo, Japan

Fresenius Medical Care Japan K.K. established Fresenius

Kawasumi Co., Ltd., which is a joint venture with Kawasumi Chemical

Industries, Co., Ltd. in 1990, and started importing and marketing

dialyzers. In 1995 a plant was constructed in Inukaicho in Oita pre-

fecture, and the manufacture and marketing of the F/FHPS series was

launched. In 1998 the import and marketing of dialysis devices for

personal use was launched, and in 2000 the import and marketing of

products for peritoneal dialysis was launched. With this the Buzen

Plant in Fukuoka prefecture was established. In 2002 the extension

of the Inugai Plant was completed and the output was increased by

2.5 times, rendering a smooth supply to the market. The product

lineup using Fresenius’s polysulfone membrane consists of the ‘PS

series (Wet),’ which has become a gold standard presence, the ‘F/FHPS

series (Dry),’ which has high quality and high suitability to the body,

and the new product ‘FX class FPX series’ which was developed by

introducing the state-of-the-art nano spinning technology, with the

goal of acquiring a new standard position this year. The artificial renal

device for personal use, 4008S, is manufactured on one common

technological platform and is characterized by upgrading to the latest

therapy, physiological monitoring, and feedback control. Under the

high corporate principles based on a high sense of mission and ethics

of using materials friendly to the living body, protecting the global

environment, improving the operation and safety of our products, and

supporting the patients, we are aiming to constantly improve the QOL

of patients with renal failure and the quality of treatment for renal

failures.

IS-4

Toray Medical’s Corporate Principles and Vision for ManagementM. Uenishi

Division of Renal Care Business, Toray Medical Co., Ltd, Tokyo, Japan

With the arrival of the 21st century, the economic environment

embracing us is changing much faster than we had anticipated, and

in every aspect of the economic world, a need for structural reform

is pressing us. Under such circumstances, Toray started ‘Project

New TORAY 21’ in April, 2002, with the goal of transforming into

a new Toray for the 21st century. In the new long-term vision for

management, we are aiming to change from a company engaged

primarily on the conventional product manufacturing business into

a 21st century type ‘New Value Creator’ that creates new values and

provides solutions to customers, by incorporating knowledge and

know-how’s for new services as well as new systems in manufactur-

ing and distribution. This is a re-confirmation of the principles

established in April, 1995, ‘Contributing to Society through the

Creation of New Values by Innovative Ideas, Technologies and

Products, and an evolvement to materialize the principles. This will

serve as the unified policy of management behavior in order to

achieve another leap in our continuing business development toward

the 21st century and is our long-term management vision which is

referred to as ‘AP-New TORAY 21.’

IS-5

Corporate Principle and ProfitabilityT. Yagi

Medical Equipment Unit, Nikkiso Co., Ltd, Tokyo, Japan

This year marks the 50th anniversary of the foundation of our

company. Prior to this, we established a new principle for manage-

ment last April of contributing to the world with creative technology

placing ‘life,’ which our company has always emphasized, and ‘envi-

ronment,’ which fosters the life, as the basis. By using the two key

words, ‘life’ and ‘environment’ which are very simple but extremely

meaningful words to replace our conventional management princi-

ples, we are convinced that all the employees can carry out their

business activities in harmony under the same concept. To value

‘life’ is a stance at securing safety. Our company has put top priority

on safety in designing, manufacturing and marketing our products.

Not only is this perception required for products manufactured by us

but also when handling any product in general. However, the more

you work on safety of the products, the more it will be difficult to

pursue profit at times when market prices are sluggish. In addition,

generally speaking, safety is not something that can be under-

stood immediately after it is used and it is often very difficult to

express ‘safety’ quantitatively. However, our share exceeds 50% in

the market of devices for dialysis. We perceive this as owing to our

customers’ appreciation of our stance toward safety, and will stay

committed in the future as well.

16 Blood Purif 2004;22(suppl 1):1–30 General Oral Presentations

IS-6

Corporate Principle and ProfitabilityM. Uesaka

Asahi Medical Co., Ltd, Tokyo, Japan

We provide products for blood purification therapies in general,

with dialysis as the centerpiece. In this session I will first introduce

the general situation of our business activities and then present an

outline of our challenges in the dialysis related field.

1. The field of our business activities: We have been operating our

business activities with the technology for blood purification ther-

apies as the core, which we acquired through the activities of man-

ufacturing and marketing dialyzers. Our current major fields of

operation are as follows, and we are performing continuous R&D

activities of blood purification therapies aiming to further

contribute to medical care.

1. The field of dialysis

2. The field of apheresis

• plasmapheresis (plasma separator, plasma component

separator/adsorber)

• cytopheresis (leukocyte adsorber)

3. The field of blood treatment for transfusion (for leukocyte

removal, for aggregate removal).

2. Operations in the field of dialysis

In dialysis, the following are perceived to be important issues:

1. Dialytic complications (dialysis-related amyloidosis)

2. Arteriosclerosis in patients on dialysis

3. Preventing initiation of dialysis by treating the underlying

disease.

As to (1) and (2), removal of low molecular weight protein and

suppression of activated oxygen is considered to be effective. We will

therefore not only expand our APS product lineup, but will also work

on the development of HDF filters and vitamin E coated membrane

and supply them to medical settings. We would also like to examine

the possibility of utilizing our technology for the treatment of under-

lying diseases such as diabetes mellitus, when introducing dialysis or

delaying the introduction of dialysis as measures against the disease.

General Oral Presentations

O-1

A Trial of Purifying the Reverse OsmosisWater for Hemodialysis with a PhotocatalystK. Yamada1, T. Fujimoto1, M. Tanaka1, Y. Harada1,Y. Kawakami1, T. Muta1, S. Fujimatsu2, H. Yamaoka3,H. Ikeuchi3

1Mizumaki Clinic, 2Ebitsu Clinic, 3Ube Industries, Ltd,Fukuoka, Japan

Purpose: To examine sterilizing and organism degenerating ability

of the photocatalytic fiber module. Equipment: The photocatalytic

fiber module, UPM-25440-80 (Ube Industries, Ltd: hereinafter referred

to as ‘photocatalyst’), was installed right before reverse osmosis (RO)

membrane, CX-MH255 (Japan Water System Corporation), with single-

path method (30 L/min). Method: The samples that the tap water, the

softened water, the post carbon fiber water and the water at entrance and

exit of photocatalyst in the RO water-treatment system, were obtained

after discharged for 5 minutes from the sample valves. Then, culture of

bacterium and endotoxin (ET) activity measurement were conducted.

The numbers of colony were counted 7 days after 1 mL of specimens

were incubated in R2A (DIFICO) and standard (Eiken-kizai) agar by the

pour plate method. ET activity was measured by Endotoxin-Specific

Assay (Seikagaku Corporation). Result: The numbers of bacteria

at the entrance of photocatalyst were 400–600/mL and 130–1,800/mL

in R2A and Standard agars, respectively. On the other hand, they

decreased to about 20/mL in both agars at the exit. ET activity were

4113.7 � 1221.5 EU/L (n � 3) in tap water, and 5,446.3 � 2,673 EU/L

(n � 3) and 5243.7 � 2309.0 EU/L (n � 3) at the entrance and exit

respectively, showing no significant difference.

O-2

Usefulness of Peracetate Purification in RO Module – The Second ReportH. Nakano, M. Nakata

Aichi Prefectural Welfare Federation of AgriculturalCooperatives Kainan Hospital Dialysis Center, Aichi, Japan

Purpose: RO module tends to cause decrease of permeation water

and ET leak due to deposit of fouling substance. As a countermeasure

against it, RO module cleaning was conducted 19 times using a reduc-

tant and peracetate, and its results were as reported in the following sec-

tions. Method: The RO module, SU-710 of TW-1200D (TORAY),

was cleaned once a month for 19 months. After rust was removed by the

reductant, DAILACHEMI MW-11, as a pretreatment, 30-minute circu-

latory cleaning and one-night inclusion were conducted using perac-

etate MINICARE. Result and Discussion: Recovery of water

quality needed 7 months in case that the cleaning was started after

membrane soil and ET leak were detected. Comparing before cleaning

and 7 months after it, ET concentration and particle number decreased

from 41.12 EU/L to 4.59 � 4.08 EU/L and from .2,358/mL to

140 � 3.44/mL, respectively, and transmission coefficient increased

from 1.39 L · cm2/hr/kg to 3.47 � 0.52 L · cm2/hr/kg (adjusted at 20C).

Conclusion: Rust removal using DAILACHEMI MW-11 was useful

as a pretreatment, and peracetate cleaning did not cause conductivity

elevation resulted from membrane deterioration, resulting in improve-

ment of transmission coefficient. Therefore, it can be concluded that

cleaning using peracetate is effective for purification of RO water and

life extension of RO module.

17Blood Purif 2004;22(suppl 1):1–309th Annual Conference of the Japanese

Society for Hemodiafiltration Therapy

O-3

Evaluation of the Dialysis Fluid PurificationSystem (TORAY Medical Co., Ltd.)Y. Tanigawa1, M. Hyodo1, J. Nagasaka1, E. Tanigawa1,C. Asakura1, Y. Sato1, H. Seno2, T. Toriyama3, H. Kawahara3

Dialysis Division of Kaikou Medical Corp., 1Hekikai KyoritsuClinic, 2Anjo Kyoritsu Clinic ,3Division of Internal MedicineNagoya Kyoritsu Hospital, Nagoya, Japan

Purpose: To evaluate the dialysis fluid purification system, on-line

HDF system (TORAY Medical Co., Ltd.) Method: The automatic

discharge system is newly employed at the terminal section to prevent

fluid stagnation in the piping. This system, installed in the dialysis

counter, consists of electromagnetic valve, pressure switch, flow

switch, and flow adjustment valve. The dead fluid during night is dis-

charged when the cleaning is started in next morning; during dialysis,

fluid discharge is conducted for one minute after 30-minute stagna-

tion. On-line HDF has TR-7000MV equipment connected in series to

two ET removal filters (TET-1.0) with flashing leak-check function.

Dialysis fluid is extracted from clean port, and new type of coupler

with air stagnation preventing function is used also. Result andDiscussion: ET concentration can keep within the level from mea-

sured sensibility or less to 2.0 EU/L in RO equipment and B original

fluid; it also keeps at the level of measured sensibility or less from

ultrafilter to console. No feversence has been reported after dialysis

with no changes in high-sensitivity CRP, resulting in continuation of

asymptomatic dialysis. Conclusion: The above-reported results

suggest that the dialysis fluid purification system, on-line HDF

system (TORAY Medical Co., Ltd.), has excellent safety.

O-4

Trial of New High-Purity Piping System(PVDF-BCF System)E. Okubo

JA Nagano Koseiren Shinanoi General Hospital, Nagano, Japan

Purpose: To maintain high-purity dialysis fluid by combination

of PVDF (polyvinylidence fluoride) piping developed by George

Fisher Inc. and BCF (Bead & Crevice Free) welding method without

difference in level. Method: In our hospital, the piping in one of the

two systems of dialysis fluid supply equipment was replaced from

Teflon (polytetrafluorethylene) lining to PVDF in December 2003.

The usefulness of this PVDF � BCF piping system was examined by

periodical measurements of ET level at the entrance, middle and ter-

minal points and incubation of dialysis fluid for six months before

and after piping replacement. Result: The endotoxin (ET) level was

lowered in PVDF piping system. In incubation test, any differences

could not be detected in both systems. Summary: Combination of

PVDF piping and BCF welding method without difference in level at

joints might contribute to decrease adhesion and proliferation of

microorganisms. Moreover, BCF welding method can lower piping

resistance, resulting in increase of flow speed in the loop piping

installed to prevent stagnation of dialysis fluid.

O-5

Examination of HDF by High-PerformanceDialyzerK. Hirano

Nakadori General Hospital, Akita, Japan

Purpose: While the removal ability of proteins with intermedi-

ate molecular weight has been improved in high-performance dialyz-

ers recently developed, they are likely to increase the transudation

amount of albumin; therefore, some of them can not be used in com-

mon HDF. The albumin removal amount and clinical effect were

examined in HDF using BS-1.8P. Method: 10 L pre-dilution HDF

using BS-1.8P was conducted on one dialysis case in our hospital, and

the removal amounts of �2-MG, �1-MG, and albumin were measured

in the entire drained fluid stored. On the other hand, clinical effects

were compared with those in other two cases and those in the same

subject with on-line HDF. Result: The average removal amounts of

�2-MG, �1-MG, and albumin were 168.6 mg, 124.2 mg, and 3.4 g,

respectively. As for clinical effects, on-line HDF could achieve more

significant pain relief. Conclusion: The removal amount of albu-

min can be diminished by pre-dilution HDF, making long-term HDF

use possible. Additionally, the replacement amount should be

increased to compare with on-line HDF.

O-6

Examination of the Replacement AmountsSuitable for Different Dilution Methods inOn-Line HDFM. Kurihara, T. Arai, Y. Suzuki, T. Okamoto, T. Honma,N. Oyama, T. Chiba, H. Hidai

Yokohama Dai-ichi Hospital, Yokohama, Japan

Purpose: The symptoms of various complications caused by

long-term dialysis treatment can be improved by Hemo-dialysis fil-

tration using HPM (high performance membrane). Recently, on-line

HDF with large amount of filtration is getting more common, obtain-

ing significant clinical effects. The various removal rates were exam-

ined for the different amounts of fluid supplementation in

pre-dilution and post-dilution methods with large supplementation in

this test. Method: The subject was a 46-year-old male patient with

thirty-year history of dialysis. The treatment was conducted at

QB 200 mL/min for four hours using PS-1.9UW. The replacement

rates were compared under the conditions of the post-dilution

method (65 mL/min) and pre-dilution method (130 mL/min and

170 mL/min). The levels of UN, Cr, Alb, and Ht were measured

before and after dialysis. Result and Discussion: The removal

rates of small and intermediate molecules in the pre-dilution method

at 170 mL/min or more were at similar levels to the post-dilution

method (65 mL/min). Generally, the fluid supplementation rate in

the post-dilution method tends to be limited due to clogged dialyzer.

When the pre-dilution method is adopted to increase the supple-

mentation rate, it should be 2.6 times or more as fast as that of the

post-dilution method.

18 Blood Purif 2004;22(suppl 1):1–30 General Oral Presentations

O-7

Clinical Evaluation of Large PolysulfoneMembrane Dialyzer in On-Line HDF UsingDifferent Dilution Methods and FluidReplacement RatesN. Suzue, K. Kawahara, T. Mizuguchi, J. Minaguchi,S. Kawashima

Kawashima Hospital, Tokushima, Japan

When post-dilution HDF is conducted, the loss of albumin increases

while the removal amount of proteins with low molecular weight, 20,000

to 30,000, such as �1-microglobulin increases. Therefore, it is quite

important to select filters in post-dilution HDF. Especially, the removal

properties of filters, i.e. albumin loss and �1-microglobulin regeneration

ability are important factors. On the other hand, the pre-dilution HDF,

controlled by on-line operation, has an advantage in regeneration of

albumin and �1-microglobulin due to less concentration of proteins at

the surface of filter membrane resulting from blood dilution. In this eval-

uation, HD, pre-dilution HDF, and post-dilution HDF have been con-

ducted using large polysulfone membrane dialyzers, APS-18E,

APS-18S, and BS-1.8P. The replacement rates are 180 mL/min,

260 mL/min, and 340 mL/min in pre-dilution HDF, and 40 mL/min in

post-dilution HDF. The removal ability of proteins with low molecular

weight and albumin loss are compared and reported through the above-

mentioned on-line HDF treatments using different dilution methods and

replacement rates.

O-8

Evaluation of Fluid SupplementationMethods in Hemo-Dialysis Filtration: Trial on Change of the Ratio of Pre- andPost-Dilution Methods – The Second ReportT. Kubo, Y. Sato, N. Abe, M. Nishiyama, T. Nishiyama,T. Shimizu, H. Kawaguchi, M. Tokiwa

Hemodialysis Unit, Iwaki Urological Clinic, Fukushima,Japan

Purpose: To examine the removal ability of the solutes such as

small molecular of substances (Cr, UN, IP, UA) and proteins with low

molecular weight (�2-MG, �1-MG) and albumin transudation in differ-

ent ratios of pre- and post-dilution methods in HDF treatment. Subject:2 male and 2 female patients aged 57.6 � 7.2, whose primary disease is

chronic glomerular nephritis, with 12.2 � 3.8 years of dialysis history.

Method: HDF, whose fluid supplementation amounts were 24 L and

36 L, were conducted in different ratios of pre- and post-dilution meth-

ods. The removal amount was calculated from the drained fluid extracted

wholly. Result: While any significant differences were not found in the

solute removal rates of small molecular substances and low molecular

weight proteins, those removal amounts and albumin transudation

showed significant differences among the test groups. Also urea rebound

amounts had no significant differences among the groups. Discussion:The results of this examination suggest that the combination method of

pre- and post-dilution might be more effective based on the removal

amounts of small molecular substances and low molecular weight

proteins. Further studies should be implemented to determine the most

suitable dialyzer for the combination method of pre- and post-dilution,

supplementation amounts of pre- and post-dilution, and to examine the

differences in treatment modes.

O-9

Examination of Various Treatment Modes of HDF such as On-Line, Off-Line, and Pre- and Post-Dilution and Indications:Effectiveness of the Dialyzer with SmallMembrane AreaS. Haneda, S. Fujimoto, N. Osumi, Y. Matsui

Matsui Clinic, Hyogo, Japan

Purpose: Although there is no doubt as to effectiveness of HDF,

selection of treatment modes is controversial. Especially, the priority of

high removal ability over albumin transudation arises much controversy.

The indications of on-line HDF and effectiveness of HDF using dialyzer

with small membrane area are described in this report. Subject:Among 64 outpatients of dialysis: on-line HDF � 34 (pre-dilution � 13

and post-dilution � 21), bottle HDF � 3, and HD � 27. Method: The

treatment effectiveness was compared in different indications, dialyzer

membrane areas used, and replacement fluid volume, using such indices

as improvement of subjective symptoms, itching scale, optimal dialysis

by urea kinetics, blood albumin level, QOL measurement, and resistance

against exercise. Result and Discussion: In on-line HDF, significant

effects on indications were found in 32 subjects among the total, 34.

Hypoalbuminemia was developed in the 2 cases of pre-dilution with

large amount fluid replacement. Especially, significant improvement of

symptoms and prevention of albumin transudation were seen in 6 cases

(1 � large replacement and 5 � small replacement) used the dialyzer

with 0.8 m2. Conclusion: These results suggest that use of dialyzer

with small membrane area might be the most effective selection for

optimal HDF treatment.

O-10

Comparison of Body Fluid TransferenceBetween Hemo-Dialysis Filtration andHemodialysisT. Ohwada, Y. Edanami, M. Nishiyama, T. Nishiyama,T. Shimizu, H. Kawaguchi, M. Tokiwa

Hemodialysis Unit, Iwaki Urological Clinic, Fukushima,Japan

Purpose: The circulation kinetics in Hemo-Dialysis Filtration

(HDF) is likely to be more stable than that in Hemodialysis (HD), gen-

erally. Using Body Composition Analyzer (In Body 3.2), body fluid

transference was compared between HDF and HD. Method: The

crossover tests of both HDF and HD were implemented for 20 subjects

suffering from non-diabetic chronic renal failure with retaining dialy-

sis treatment. The body fluid weight is measured by In Body before

19Blood Purif 2004;22(suppl 1):1–309th Annual Conference of the Japanese

Society for Hemodiafiltration Therapy

and after HDF/HF, and blood test was conducted to calculate the mean

Kr. Then, those results were compared between HDF and HD. Result:The variations of the ratios between ICF (intracellular fluid) and ECF

(extracellular fluid) and between ISF (interstitial fluid) and TBW (total

body fluid weight) ( ISF/ TBW) before and after water removal

showed excellent correlations in both HDF and HD. In HDF, however,

those tend to vary more widely. The mean Kr showed adverse correla-

tions with plasma volume ( PV) and with the ratio between plasma

volume and ISF ( PV/ ISF) in both HDF and HD. Discussion andConclusion: The variations of ICF, ECF, and ISF in HDF were larger

than those in HD; the mean Kr in HDF was higher than that in HD.

However, those differences were not statistically significant.

O-11

Clinical Comparison of Removal EfficiencyBetween HDF and HDY. Sakai1, H. Kawanishi2, A. Sekinaga1, T. Tanigawa1,M. Moriishi1, S. Tsuchiya1

1Nakajima Tsuchiya Clinic, 2Tsuchiya General Hospital,Hiroshima, Japan

Preface: Recently the performance of dialyzer has been greatly

improved, making removal of proteins with low molecular weight

possible even in the HD mode, while on-line HDF with pre-dilution

(pre-HDF) is commonly implemented in our clinic. Therefore,

removal effects between HD and pre-HDF are compared in this study.

Subject and Method: 68 subjects without hospitalization since

August 2001 were selected among our outpatients (49 for HD and 10

for pre-HDF). The values of BUN, �2-MG, Alb, CRP, and Ht were

compared before treatment; administrated EPO volume and Dwt

alteration were compared also. PS membranes were used for dialyz-

ers in both cases. The values of QB were 202.0 � 37.0 mL/min and

218.4 � 49.0 mL/min in the HD group and pre-HDF group, respec-

tively. QF was 228.9 � 57.8 mL/min. Result: According to the

observation for about two years, there were no significant differences

in BUN and �2-MG before treatment (BUN: 67.3 � 13.6 mg/dL in

HD and 67.3 � 13.6 mg/dL in pre-HDF, �2-MG: 24.5 � 5.7 mg/l in

HD and 25.7 � 7.6 mg/l in pre-HDF). Moreover, in Hct and adminis-

trated EPO volume, HDF showed a little excellent result but not so

significant advantage. In both HD and HDF, the values of solutes

before treatment rapidly decreased due to circulation increase, and

anemia was improved. Conclusion: HDF could not have significant

advantages in removal of the substances with mol wt up to �2-MG

due to improvement of dialyzer performance. Further studies should

be conducted to evaluate the removal efficiency of bigger mol wt such

as �1-microglobulin.

O-12

Experience of Daily HFT. Nishimura, M. Oki, A. Kai, H. Kurose, H. Kawanishi,S. Tsuchiya

Tsuchiya General Hospital, Hiroshima, Japan

Purpose: Recently, daily short hemo-filtration attracts great

attention in dialysis treatment. Although home hemodialysis needs

special equipments such as a water treatment machine, hemofiltration

can be easily conducted at home using simple equipment and supple-

ment fluid. The comparison results between three-time-a-week

HD and daily short HF were reported in this paper. Subject andMethod: The subjects were 5 hospitalized dialysis patients with sta-

ble conditions. In the first week, four-hour HD was conducted three

times a week as usual; HD efficiency was evaluated by collecting

all the discharged dialysate at the middle of the week. In the second

week, two-hour HF (post-dilution) was conducted six times a week;

single HF efficiency was evaluated by whole pool of removed water at

the first day of the week. Furthermore, the removal efficiency by week

was calculated and compared between the two. The filtration volume

was set at approximately 40% of body fluid (V) including removed

water. FPX (Fresenius Medical Care) were used for the dialysis mem-

branes. Result and Discussion: The removal efficiencies by week

of urea were 5.58 � 0.63 mL/min (Kt/V: 2.24 � 0.13 mL.min) and

4.86 � 1.14 mL/min (Kt/V: 1.9 � 0.2 mL/min) in HD and HF, respec-

tively; on the other hand, those of �2-MG were 1.52 � 0.26 mL/min

and 1.92 � 0.58 mL/min in HD and HF, respectively. Consequently,

daily HF could keep the removed volume of urea at weekly Kt/V 2.0;

that of �2-MG in daily HF could exceed that in HD. Conclusion:Daily HF could show sufficient removal efficiency.

O-13

Experience of Extended Daily HF for AcuteHemo-CatharsisK. Hoshiko, M. Oki, A. Kai, H. Kurose, R. Ago,H. Kawanishi, S. Tsuchiya

Tsuchiya General Hospital, Hiroshima, Japan

Purpose: The most suitable hemocatharsis treatment method for

different disease conditions can be selected due to improvement of

acute hemocatharsis treatment. The extended daily HF using optimal

filtration volumes suitable for different disease/circulation conditions

was conducted in our hospital. Method: The filtration volumes per

24 hours (QF) were set at approximately GFR 15–30 mL/min (the stan-

dard body fluid volume � 40 L) according to the disease/circulation

conditions. The post-dilution hemofiltration was conducted, whose

blood flow and QF were gradually raised according to the circulation

increase within 80–150 mL/min and 10–50 mL/min, respectively.

When the filtration volume reached the target value, the treatment was

ended. FPX100 (Fresenius Medical Care) were used for the dialysis

membranes. The removal efficiencies of urea and �2-MG were evalu-

ated by extracting the entire discharged fluid and calculating the clear

space as equivalent renal clearance (ekr: ekr � clear space

rate � standard body fluid volume/24 � 60). Result: At GFR

20 Blood Purif 2004;22(suppl 1):1–30 General Oral Presentations

20 mL/min, the time for treatment was 8–20 hours, and the ekr values

of urea and �2-MG were 17.2 mL/min and 7.8 mL/min, respectively;

on the other hand, at GFR 15 mL/min, the time for treatment was

6–12 hours, and the ekr values of urea and �2-MG were 13.6 mL/min

and 6.9 mL/min, respectively. Conclusion: In the extended daily HF

we conducted, the time for treatment was adjusted by circulation con-

ditions based on the established QF. This method might be an option of

acute hemocatharsis treatment.

O-14

Supply of Purified Dialysis Fluid by Disposal JointS. Moriwaki1,2, A. Arai1, Y. Hanakura1, S. Uemura1,T. Toyoko1, K. Ajino1, N. Takagi1

1Bosei Kannai Clinic, 2Showakai group, Yokohama, Japan

Purpose: In dialysis treatment, the couplers whose contamination

by endotoxin (ET) is reduced are used and maintained to supply puri-

fied dialysis fluid. Such couplers, however, could be a contamination

source without appropriate maintenance and regular cleaning and dis-

infection. Therefore, safe and cost-effective disposal couplers should be

developed as soon as possible. In our clinic, disposal joints mounted at

the entrance for dialysis fluid supply and used with conventional cou-

plers were designed and made for a trial, and our evaluation results of

its usefulness are reported in this paper. Method: ET levels were mea-

sured and compared in the cases with and without coupler joint, using

some different sorts of coupler joint. Result: ET level could be sig-

nificantly lowered by use of coupler joint. Also coupler joint use might

have such advantages as excellent stableness, safety, and durability.

Conclusion: The disposal joint can be supplied with the cap of the

section for supply of purified dialysis fluid, preventing contamination

of O ring in coupler without special accessories.

O-15

Evaluation of Various Detergents Made by Different Manufacturers According to the Property to Rust PipingH. Nakamura, K. Itou, K. Murakami

Clinical Engineering Group, Mie Prefectural GeneralMedical Center, Mie, Japan

Various detergents for different purposes on the existing dialysis

piping are available: e.g., that containing chlorine for washing, steril-

ization and disinfection, that containing acetic acid to remove carbon-

ate, and supplementary and rust preventing chemicals used commonly.

Recently, peracetate and acidulous/acidic water are also used in some

facilities. In our medical center, alkaline detergent and peracetate have

been used in combination daily since about two years ago. It can be a

comprehensive method to remove organisms and carbonates and to

sterilize at the same time. The main purposes of detergents are steril-

ization, disinfection, and soil removal, of course. They, however, may

directly cause corrosion of piping; therefore, it is quite important to

choose most suitable detergents for the equipments. According to the

property to rust piping, various detergents made by different manufac-

turers are compared and evaluated, and also our washing system is

reexamined based on the easy-rusting property.

O-16

Investigation of Water Quality Control atDialysis Facilities in Niigata PrefectureH. Goto1, S. Hasegawa2, I. Nakagawa3, F. Nakamura4

1Niigata Association for Clinical Engineering Technologists,Santo Second Clinic, 2Blood Purification Center, NiigataUniversity Medical Hospital, 3Nishikawa Clinic, ShinrakuenHospital, 4Kidney Center, Sinrakuen Hospital, Niigata, Japan

Purpose: To investigate the existing situation of water quality

control at dialysis facilities in Niigata Prefecture. Method: The

investigation by questionnaire on water treatment and water quality

control was implemented to 51 dialysis facilities in Niigata

Prefecture, and the endotoxin (ET) test by dialysis fluid sampling was

implemented in 49 facilities among them on December 2002. The fol-

lowing three samples were extracted: original (tap) water, RO water,

and dialyzed fluid (at the terminal console). The same sampling

method as in the national survey conducted by HDF research group

in 2002 was used. Result: The mean ET levels of original water, RO

water, and dialyzed fluid were 1,250 EU/L, 4.1 EU/L, and 6.9 EU/L

respectively; all of them were less than the national average.

Conclusion: The ET levels of dialysis fluid at most facilities in

Niigata Prefecture met the standard level established by The Japanese

Society for Dialysis Therapy, 50 EU/L or less.

O-17

Report on Use of Bio-Free CouplerT. Maeda, S. Hashiguchi, E. Yoshimura, K. Nishimoto,M. Ogawa, K. Shiraishi, K. Arizono, H. Fukui

Kumamoto Chuo Hospital, Kumamoto, Japan

Preface: The contamination in coupler is the most important

problem in dialysis fluid purification of P/PHDF and on-line HDF. As

the countermeasures against it, different sorts of improved couplers and

various cleaning methods have been developed so far. Our hospital also

has been trying to improve purification in coupler. Consequently, use of

bio-free couple without bypass connector showed excellent results, as

reported at the 9th Kyushu HDF study meeting. Purpose: Bio-free

coupler was used for 18 months in our hospital, and its easiness to use

and durability were examined along with ET level measurement and

bacteria incubation test. Method: ET level had measured in front and

in rear the coupler every two weeks and bacteria incubation test in cou-

pler had conducted every three months since the bio-free coupler was

started to use. The number of dialysis fluid leak from coupler was

counted also. Result: Throughout its use for 18 months, ET levels in

21Blood Purif 2004;22(suppl 1):1–309th Annual Conference of the Japanese

Society for Hemodiafiltration Therapy

front and in rear the coupler were less than the detectable sensitivity

except for once, and the results of bacteria incubation test were nega-

tive also except for once. The number of fluid leak from coupler was

twice among 13,000 times of dialysis using bio-free coupler.

Conclusion: The bio-free coupler showed almost no deterioration

during its long-term use for 18 months. Bacteria proliferation could be

hardly found, and ET level could be kept less than the detectable

sensitivity without special techniques.

O-18

Clinical Evaluation of the Internal-Filtration-Promoted Dialyzer, BS-1.6UL – Examination of OptimalTreatment ModeR. Sayama1, S. Nogawa1, M. Saito1, Y. Morimoto1,R. Oishi1, Y. Sato1, H. Ito2, H. Ogata2, E. Kinugasa2,T. Kobayashi3

1Department of Medical Engineering, Showa UniversityNorthern Yokohama Hospital, 2Department of InternalMedicine, 3Department of Medical Engineering, ShowaUniversity Fujigaoka Hospital, Yokohama, Japan

Purpose: The internal-filtration-promoted dialyzer has been

improved to increase the removal performance of proteins with low

molecule weight. Its solute removal ability using BS-1.6UL(UL) was

evaluated in various HDF treatment methods, compared with the con-

ventional type of dialyzer BS-1.6U(U), and its optimal treatment

mode was examined. Subject and Method: HD and on-line HDF

(post 10 L, Pre 30 L & 50 L) were conducted on 6 dialysis patients

with stable conditions using U and UL. The solute removal perfor-

mance in each treatment method was evaluated. Result: The

removal performance of small molecule substances showed no differ-

ences between both types of dialyzer and among different treatment

methods. On the other hand, the removal rate of proteins with low

molecule weight (� 2-MG, Myo, � 1-MG) showed high levels in Post

10 L and Pre 50 L, compared with HD. Although significant differ-

ences were not found between both dialyzers in all treatment methods,

UL tended to indicate a little higher solute removal ability than that of

U. The maximum of albumin loss was 2.8 g in post 10 L using UL.

Conclusion: In the case using BS-1.6UL, post dilution on-line HDF

10 L might be the optimal dialysis mode according to the removal

ability of proteins with low molecule weight and cost-effectiveness.

O-19

Use Experience of Internal-Filtration-Promoted Dialyzer FPX – Examination in Both HD and HDF ModesN. Ono1, A. Goto1, K. Tanabe1, K. Hara1, I. Matsuyama1,H. Goto2, T. Nakamura2, K. Matsuyama3, T. Tomo3, M. Nasu3

1Medical Corporation Seiikai Matsuyama Clinic, 2MedicalCorporation Keiaikai Oitanakamura Hospital, 3SecondSchool of Internal Medicine, Medical College of Oita, Oita,Japan

Purpose: To examine the removal ability of each solute and

radical-related markers of the internal-filtration-promoted dialyzer

FPX in both HD and HDF modes. Method: Using PS-UW and FPX,

HD (QB � 200 ml, QD � 500 ml, for 4 hours) and on-line HDF (Pre-

dilution: QB � 250 ml, QD � 500 ml, replacement fluid volume � 58 L,

Post-dilution: QB � 250 ml, QD � 500 ml, replacement fluid

volume � 18 L) were conducted on 4 dialysis patients with stable

conditions, and the removal ability of small molecule substances and

proteins with low molecule weight and alteration rates of radical-

related markers (T-pentosidine, T-CML, F-pentosidine, and F-CML)

were examined. Result: The alteration rates of radical-related mark-

ers were as follows: In HD, T-pent of FPX and PS were 7.5% and 4%

and T-CML were 19.4% and 10% respectively, resulting in large

decreasing rate of FPX. In HDF, on the other hand, T-pent of FPX-pre,

PS-pre, FPX-post, and PS-post were 1.3%, 5.3%, 4.5%, and 7.8% and

T-CML were 10.8%, 11.4%, 17.2% and 12.4% respectively, resulting

in the largest decreasing rate of FPX-post. Conclusion: According

to the above results, the decreasing rates of radical-related markers of

FPX were likely to be higher than those of PS-UW in HD; however,

any significant differences in those alteration rates between the two

were not found in HDF. Therefore, it suggests that FPX might be more

effective in HD than in HDF.

O-20

Examination on Usage of Fine-Mesh Hollow MembraneH. Kanekawa1, H. Hatakeyama1, K. Ashimine1,T. Kanazashi1, N. Fujii1, H. Iguchi1, T. Ikeuchi2,A.C. Yamashita3

1Chuo-Rinkan Hospital, 2Showa-University-FujigaokaHospital, 3Department of Materials Science andEngineering, Shonan Institute of Technology, Kanagawa,Japan

Preface: The fine-mesh hollow membrane has promotion effect

of internal filtration, demonstrating its effectiveness for treatment.

However, since the promotion effect of internal filtration greatly

relies on blood flow, its efficient internal filtration might not be

obtained by usual dialysis. The clinical usefulness of fine-mesh hol-

low membrane was examined in various treatment methods.

Method: The clearance, removal rate, and clear space of UN, Cr, iP,

� 2-MG, myoglobulin, � 1-MG were measured and compared among

22 Blood Purif 2004;22(suppl 1):1–30 General Oral Presentations

HD, hemodialysis re-circulation (PBR-HD), and on-line HDF (Pre-D,

Post- D) on 5 dialysis patients. Result: The clearance, removal rate,

and clear space of middle to large molecule solutes were HD�PBR-

HD�on-line HDF. While the fine-mesh hollow membrane has pro-

motion effect of internal filtration, there were any significant

differences in those values compared with other sorts of membrane.

In this study, the blood flow and re-circulation volume were estab-

lished at 200 mL/min and 300 mL/min respectively in HD and PBR-

HD, resulting in no significant differences also. In on-line HDF, on

the other hand, filtration volume could not be increased because TMP

was elevated by filtration flow increase. Conclusion: No significant

differences in the promotion effect of internal filtration by fine-mesh

hollow membrane were demonstrated among various treatment

modes. The effective method to improve internal filtration should be

developed in the future.

O-21

Solute Removal Ability in HDF UsingFPX140K. Murakami

Fujita Health University Hospital, Aichi, Japan

Purpose: To examine the solute removal ability in HDF using

FPX140. Subject and Method: HD and HDF (post-dilution, 10 L

replacement) were conducted on 5 dialysis patients using FPX140 and

PS1.3UW for one week each as the crossover test. The dialysis condi-

tions were as follows: for 4 hours in all cases, QB � 200 ml, and

QD � 500 ml. The removal rate, clearance, clear space, and removal vol-

ume were measured and compared between the two dialyzers. Result:Any significant differences in the clearance and removal rate of the sub-

stances with low molecule weight were not found; the clearance and

removal rate of � 2 MG were 54.6 � 8.1 mL/min and 62.4 � 0.5% in

HD using FPX, 50.6 � 4.5 mL/min and 58.5 � 7.6% in HD using

PSUW, 59.5 � 4.3 mL/min and 72.7 � 8.3% in HDF using FPX, and

62.3 � 5.8 mL/min and 73.6 � 7.5% in HDF using PSUW, respectively.

On the other hand, the clearance and removal volume of � 1 MG showed

steadily low levels under all conditions, resulting in almost no differ-

ences between the sorts of dialyzer. Albumin loss was 0.5 g or less in

all cases. Conclusion: This study indicated that FPX had almost

equivalent solute removal ability to PSUW in HD and HDF.

O-22

Clinical Measurement of Internal Filtration Flow Using Ultrasonic WaveK. Ozawa, I. Ishimori, T. Yokote, I. Kaneko, Y. Sato,M. Mineshima, T. Akiba

Department of Blood Purification, Kidney Center, TokyoWomen’s Medical University, Tokyo, Japan

Preface: Internal filtration may occur in dialysis using the exist-

ing dialyzer with high permeability. To examine actual situations,

internal filtration flow was clinically measured by the ultrasonic

Doppler method. Method: The measurements were conducted

7 times with BS-1.8UL (TORAY Medical Co., Ltd.) and 11 times

with APS-18S (ASAHI Medical Co., Ltd.), 18 times in total. The

blood linear velocity profile in the longitudinal direction of dialyzer

was measured by the Doppler ultrasonic method every one hour after

the treatment was started under the following conditions: blood

flow � 200 mL/min, dialysis fluid flow � 500 mL/min, and net ultra-

filtration volume � 0 L/hr. Result and Discussion: The measure-

ments of internal filtration flow using ultrasonic wave could be safely

conducted without any clinical troubles related to measurement. The

occurrence of internal filtration was detected in all 18 times of

measurements; its flow was 14.47 mL/min and 10.33 mL/min in BS-

1.8UL and APS-18S respectively. Although the existing dialyzers

show internal filtration at some extent, internal-filtration-promoted

types should be improved further.

O-23

Alteration of Substance RemovalEffectiveness and Living Body Compatibility Because of Dialyzer ChangeF. Takahata1, H. Tado1, M. Kanazawa1, T. Tsuchiya1,T. Saito1, K. Sakurai1, A. Takezawa2, A.C. Yamashita2, T. Sakai3

1Hashimoto Clinic, 2Department of Materials Science and Engineering, Shonan Institute of Technology,3Children Kidney Center, Kanagawa, Japan

Purpose: Some reports suggest that substance removal effec-

tiveness may decrease due to long-term use of the same dialyzer.

Whether such phenomenon actually occurs or not was examined as

well as the indexes related to living body compatibility. Subject andMethod: One HD patient and also one on-line HDF patient who

have been using the dialyzer with PS membrane (NK-PS15S) for long

time were chosen as the subjects of this study. After different dialyzer

with PEPA membrane (FDY-15GW) was used on them for 5 weeks,

PS membrane dialyzer was used again. The same treatment conditions

were applied to the both cases. The blood level, clearance, clear space,

and total removal volume of UN, Cre, � 2 MG, and � 1 MG were mea-

sured before and after the treatment once a week. Furthermore, WBC,

C3a, IL-6, and TNF-� were chronologically monitored as the indexes

to evaluate living body compatibility with different membranes.

Result: During use of PEPA membrane for 5 weeks, the substance

removal effectiveness did not show any significant variations. On the

other hand, C3a showed significant differences between the two dia-

lyzers; it decreased about one week after change to PEPA membrane,

and elevated again after the similar time lag from return to PS mem-

brane. Conclusion: While significant alteration of substance

removal effectiveness was not found for 5 weeks, this study suggests

that dialyzer change might be a stimulus on organisms. Further stud-

ies should be conducted for longer observation, taking living body

compatibility with membranes into consideration.

23Blood Purif 2004;22(suppl 1):1–309th Annual Conference of the Japanese

Society for Hemodiafiltration Therapy

O-24

Basic and Clinical Evaluation of FDYDialyzer with Hydrophilic PEPA MembraneM. Kanazawa1, H. Tado1, F. Takahata1, T. Tsuchiya1, T. Saito1,K. Sakurai1, A. Takezawa2, A.C. Yamashita2, T. Sakai3

1Hashimoto Clinic, 2Department of Materials Science andEngineering, Shonan Institute of Technology, 3ChildrenKidney Center, Kanagawa, Japan

Purpose: To examine the solute removal ability and living body

compatibility of FDY dialyzer with large-mesh hydrophilic PEPA

membrane from basic and clinical points of view. Subject andMethod: The albumin sieve coefficients in water solution of three

sorts of dialyzer with PEPA membrane (FLX, FDX, and FDY) were

measured in basic study. In clinical study, on the other hand, HD and

HDF were conducted on the dialysis patients at their stable stage

using FDY. The removal rate, clearance, and clear space of UN, Cre,

� 2 MG, and � 1 MG and Albumin leak volume were measured in var-

ious treatment modes (different dialysis methods and fluid replace-

ment volume), compared with those of PS membrane dialyzer

NK-PS. The organism compatibility was evaluated using WBC, IL-6,

and TNF-�. The effect of blood flow variation (200→300 in HD,

220→260→300 in on-line HDF) on solute removal ability was exam-

ined also. Result and Conclusion: The albumin sieve coefficients

measured in water solution were FLX� FDY� FDX; FDY might

show intermediate value because of the effects by large-mesh

hydrophilic membrane. Moreover, FDY clinically had equivalent

removal performance to NK-PS against the substances with small

molecule weight to � 2 MG level despite of low albumin loss. In

evaluation of organism compatibility using C3a, FDY also showed

excellent results, suggesting that it might be adaptable to both HD and

HDF modes.

O-25

Effect of Large-Mesh Hydrophilic Membraneon Sieve CoefficientN. Tomisawa, A. Takezawa, A.C. Yamashita

Department of Materials Science and Engineering,Shonan Institute of Technology, Kanagawa, Japan

Purpose: Effect of membrane material and albumin concentration

on sieve coefficient was examined using albumin solution. Method:Using Dialyzers made by NIKKISO Inc., FLX-15GW (not containing

PVP, standard fine-mesh), FDX-15GW (containing PVP, standard fine-

mesh), and FDY-15GW (containing PVP, large-mesh), the sieve coeffi-

cients (s.c.) were measured in the water solution containing 1.21, 2.42,

3.64 mg/mL of albumin as a single component at 37C (fixed). The

experiment was conducted for 630 minutes at QB � 200 mL/min and

QF � 10 mL/min. Result and Conclusion: In all the cases using dif-

ferent three dialyzers, the steady state could be achieved for shorter time

at higher albumin level of the test solution, indicating lower s.c. This can

be demonstrated using the model of gel-polarization. The absolute val-

ues of sieve coefficient were FLX�FDY�FDX. This result might be

caused by the effects of hydrophilia due to PVP and large-mesh.

O-26

Measurement of Sieve Coefficient UsingWater Solution with Multi ComponentsIncluding AlbuminA. Takezawa, N. Tomisawa, A.C. Yamashita

Department of Materials Science and Engineering,Shonan Institute of Technology, Kanagawa, Japan

Purpose: The sieve coefficients were measured using the solu-

tion with two components including albumin in order to evaluate fil-

tration performance of dialyzers. Method: The sieve coefficients

were measured in the solution with two components including albu-

min and cytochrome C using PS-1.0UW (PS membrane) made by

Fresenius Kawasumi at 37C (fixed). The experiment was conducted

for 300 minutes at QB � 200 mL/min and QF � 10 mL/min. Result:In the case using the solution with single component of albumin at

3.64 � 10�5 mol/L (2.40 mg/mL), the sieve coefficient increased for

20 minutes after the experiment was started, and then gradually

decreased, showing the fixed level later. Using the solution containing

cytochrome C as a single component at 2.16 � 10�5 mol/L

(0.27 mg/mL), the sieve coefficient increased for 20 minutes from the

beginning of experiment, and then indicated the fixed level. On the

other hand, in the case using the solution with two components of

albumin and cytochrome C, the sieve coefficient drew quite similar

curve to the cases of single component solution, and the absolute

value was almost the same as them also. While two sorts of protein

components with almost the same molar concentration tend to deposit

on the membrane surface, it was not significantly observed on PS

membrane. Conclusion: The results of this study suggest that the

sieve coefficient of cytochrome C on PS membrane is not influenced

by existence of albumin.

O-27

Examination of Internal Filtration Flow in Continuous High Flux DialysisS. Yoshimura1, M. Hokkyo1, M. Kaneko1, M. Kuroda1,J. Fujii1, Y. Kabeta1, N. Nakagawa1, R. Yamada1,A.C. Yamashita2

1Research and Development, JMS Co., Ltd., 2Department of Materials Science and Engineering,Shonan Institute of Technology, Kanagawa, Japan

When HD is conducted using high-performance membrane with

high permeability, the internal filtration flow may reach the level equiv-

alent to HDF filtration flow, resulting in great effect of dialysis condi-

tions on removal efficiency. On the other hand, the internal filtration

flow of continuous treatment used in acute hemocatharsis is generally

lower than that of intermittent treatment such as HD because moderate

flow conditions are often applied to the former. However, the internal

filtration has great meanings in continuous treatment; e.g., no risk of

contamination by endotoxin due to use of sterilized medicines, possi-

bility that even little amount of internal filtration affects removal effi-

ciency due to continuation for long time, etc. Therefore, the internal

24 Blood Purif 2004;22(suppl 1):1–30 General Oral Presentations

filtration flow in continuous high flux dialysis was examined in this

study. The continuous treatments were conducted using bovine blood at

QB � 100 mL/min for 24 hours in the following modes: CHD

(QD � 1 L/hr), CHF (QS � 1 L/hr), and CHDF (QD � QS � 0.5 L/hr).

Based on the mathematical model, the internal filtration flow was cal-

culated using BIOPES membrane (1.1 m2 module) as a typical highly

permeable membrane. As a result, the internal filtration flows were

CHD�CHDF�CHF; those per hour were 0.1–0.5 L/hr. It suggests that

improvement of removal efficiency by internal filtration can be

expected in the continuous treatment using the membrane with high

permeability.

O-28

Clinical Evaluation of Various TreatmentModes in On-Line HDFK. Nagasawa1, M. Takagi1, N. Kamei1, M. Takeda1,D. Inoue1, K. Sato1, K. Turusawa1, M. Nishihara1,H. Shishido1, T. Kobayashi2

1Sekishinnkai Kawasaki Clinic, 2Showa-University-Fujigaoka Hospital, Yokohama, Japan

Purpose: The solute removal performances of HD and different

dilution methods of on-line HDF were evaluated using various poly-

sulfone membranes. Subject and Method: The subjects of this

study were 6 dialysis patients at their stable stage (age: 50.4 � 9.9,

dialysis history: 10.9 � 7.0). The removal rate and volume of � 2-MG

and � 1-MG and albumin loss were compared and examined in HD

and post-dilution 10 L and pre-dilution 30 L of on-line HDF using

BS-1.6UK(BS), APS-15S(APS), and PS-1.6H(PS). Result: The

solute removal performances of the substances with small molecule

weight did not indicate any differences in different treatment methods

in all cases using BS, APS, and PS. The removal ability of proteins

with small molecule weight such as 10,000–30,000 dalton in HD was

higher than that in Post-10 L; however, no significant differences were

seen between that in HD and Pre-30 L. On the other hand, albumin

loss of Post-10 L was significantly higher than that of HD in all cases

using three sorts of membranes; that in Post-10 L was BS�APS�PS.

Conclusion: In different dilution methods of on-line HDF, the

removal rate of proteins with small molecule weight and albumin loss

might depend upon the membranes made by different manufacturers.

Therefore, treatment modes should be chosen properly taking

membrane performance and patient conditions into account.

O-29

The Performance Examination in DifferentTreatment Modes Using the Dialyzer withVarious Filling RatesS. Yoshigami, H. Ogawa, I. Matsuyama

Oita Naika Clinic, Oita, Japan

Purpose: PS membrane has been used in various hemocatharsis

methods including hemodialysis. Whether the performance in various

treatment modes depends upon different filling rates of the dialyzer

using PS membrane was examined in this study. Subject andMethod: Three male dialysis patients with stable conditions were

chosen as the subjects. Using the membranes with the same quality,

module length, and area, the filling rates of dialyzer were established

at 58.9%, 47.7%, and 39.4%. The crossover test was conducted in HD

and on-line HDF with different replacement fluid volumes and

replacement methods, and the removal rate and volume and clearance

of substances as well as albumin loss were measured and compared

among the cases. The reverse filtration volume during dialysis was

measured also. Result: In HD, the removal rate of small mol-wt sub-

stances was higher in the case using higher filling rate. However, the

removal rate of � 2-MG in pre-HDF was different from that in HD

and post-HDF. The reverse filtration volume during dialysis was high-

est in the case using 58.9%, followed by 47.7% and 39.4%.

Discussion and Conclusion: The reverse filtration volume of the

dialyzer whose filling rate is high is generally higher than that of

other types of dialyzer due to its large loss of dialysis fluid pressure,

resulting in improvement of removal ability of � 2-MG. The results of

this study indicate that membrane material, filling rate, inside diame-

ter, vessel shape (L/D), etc. should be considered in HD and HDF.

O-30

Examination of Solute Removal Performancein Constant and Pulse Flow MethodsY. Tange1, H. Kawakami1, H. Oguma1, Y. Ito1, A. Morizane1,H. Sato1, M. Nakayama2, T. Murakami3, S. Takesawa4

1Nagoya Memorial Foundation Tokai Clinic, 2NagoyaMemorial Foundation Tokai-Chita Clinic, 3Shinseikai DaiichiHospital, 4Suzuka University of Medical Science, Nagoya,Japan

Purpose: There are two methods to supply the dialysis solution:

constant flow type and pulse flow type. In this study, the differences in

solute removal performance between two sorts of console were exam-

ined in on-line HDF. Method: Using two sorts of console, on-line

HDF was conducted on 5 outpatients under HDF treatment, applying the

same dialysis conditions. TR-321 (TORAY) and DBB-26 (NIKKISO),

remodeled for on-line use, were used for the consoles. Result: While

no significant differences in the clear space of small mol-wt substances,

Cr and iP, were found, that of UA showed significant increase in the

pulse flow method. The removal volume of � 2-MG in the group using

PS-UW significantly increased in the pulse flow method. The removal

rate of low-molecule-weight protein, � 2-MG, also significantly

25Blood Purif 2004;22(suppl 1):1–309th Annual Conference of the Japanese

Society for Hemodiafiltration Therapy

increased in the pulse. On the other hand, any significant differences in

prolactin were not seen in both groups; �1-MG in the constant flow

method increased more significantly than that in the pulse.

Conclusion: These results suggest that the dialysis solution supply

methods might cause the differences in solute removal performance also

in on-line HDF.

O-31

Change of Pentosidin Level in Blood among Chronic Hemodialysis Patients in an Endotoxin-Free Environment Startingfrom RO SystemM. Taoka1, Y. Izuhara2, I. Tanaka1, H. Kuroda1,Y. Yoshikawa1, K. Jinde1, T. Miyata2, A. Saito2, K. Kurokawa2

1Bosei Ohne Clinic, 2Tokai University, Kanagawa, Japan

Objective: The endotoxin (ET) concentration of dialysate,

which was previously at 20 to 30 EU/L, was made practically ET-free

from the RO module to the downstream end of the hemodialyzer by

water quality management. We examined changes of the pentosidin

level of chronic maintenance hemodialysis patients over time.

Method of Study: We introduced in October 2001 a RO system

Pureflow manufactured by JMS, which brought the ET level of

dialysate to below the detectable level. We recorded and compared the

pentosidin level and other blood parameters of the patients: prior to,

and 3 months (3 M) and 6 months (6 M) after the introduction of the

ultra-pure dialysate environment. Results: The level of pentosidin,

which was 1.55 � 0.61 prior to the RO system introduction, became

1.38 � 0.52 at 3 M and 1.31 � 0.50 at 6 M (nM/mL) (p � 0.0001);

likewise the level of TG, which was 150 � 116 before, became

124 � 79 at 3 M and 119 � 75 at 6 M (mg/dL) (p � 0.01), both sta-

tistically significant changes (mean � SD). We could not find any

statistical correlation between pentosidin and TG. There was no

significant change in �2-MG and anemia. Conclusion: We have

found that in the ET-free dialysate environment starting from the RO

module downward, the production of pentosidin is inhibited.

O-32

Influence of Dialysis Modality on Serum IL-6 and sCD14H. Igarashi1, M. Matsuzawa2, T. Nishimura3, M. Nanbu4, I. Masakane5

1Kidney and Dialysis Center, Yabuki Hospital, Departments of 1Clinical Engineering, 3Internal Medicine, Akebono Hospital, 4Kidney Center, KitasatoUniversity Hospital, 5Department of Internal Medicine,Yabuki Hospital, Yamagata, Japan

Objectives: We examined changes in serum IL-6 and sCD14

depending on dialysis modalities. Patients and Methods: Seven

stable chronic hemodialysis patients were enrolled in the study.

Hemodialysis and on-line HDF were performed under conditions

such as dialysis membrane of polysulphone, blood flow rate of

200 ml/min., total dialysate flow rate of 500 ml/min and filtration flow

rate of 200 ml/min. Blood samples to evaluate serum levels of IL-6

and sCD14 were drawn from the blood line prior to and after thera-

peutic sessions. Results: In HD therapies, serum levels of IL-6

changed from 1.06 � 1.46 pg/mL before the therapy to 1.31 � 1.70

after the therapy. Likewise, the serum levels of sCD14 changed from

6.1 � 1.4 �g/mL prior to the therapy to 5.4 � 1.6 after the therapy. In

on-line HDF therapies, the levels of IL-6 changed from

1.87 � 1.32 pg/mL prior to the therapy to 0.79 � 0.75 after the ther-

apy. The levels of sCD14 changed from 6.1 � 1.2 �g/mL prior to the

therapy to 6.7 � 0.8 after the therapy. There were statistically signif-

icant changes in sCD14 in HD therapy and both IL-6 and sCD14 in

on-line HDF therapy. Discussion: IL-6 were effectively removed

from blood by filtration because of its molecular weight, so serum

levels of IL-6 reduced in on-line HDF but increased in HD. On the

other hand, the levels of sCD14 declined in HD therapy but increased

in on-line HDF therapy. These results suggest that even if ET levels of

dialysate may be below the detection level, a weak inflammatory reac-

tion may be induced in on-line HDF therapy. We supposed major

mechanisms of this phenomenon to be subtle bacterial contamination

or acetate and so on. To resolve this question we have to examine the

influence of variations of modality such as acetate free biofiltraion

and of variations of dialysate contaminations on serum sCD14 and

IL-6 levels. Conclusions: Dialysis modalities could change the lev-

els of serum IL-6 and sCD14, and further examinations should be

needed to solve the mechanism.

O-33

A Clinical Case of Chronic RheumaticArthritis for Which On-Line HDF Therapy Was EffectiveH. Seno1, Y. Tanigawa1, Y. Sato2, T. Toriyama3, H. Kawahara3

1Dialysis Division of Kaikou Medical Corp., AnjoKyoritsu Clinic, 2Hekikai Kyoritsu Clinic, 3Division ofInternal Medicine, Nagoya Kyoritsu Hospital, Nagoya, Japan

Objective: Report a case of chronic rheumatic arthritis (RA)

patient for whom on-line HDF was effective. Case: A male patient age

71 with chronic glomerulonephritis had been on dialysis for one year.

He started dialysis in July 2002. RA symptoms at both knees and shoul-

ders with pain continued, and the rheumatoid factor remained high

from 214, 178, 181, 143 to 126 U/mL during September–December of

2002 and CRP also remained high from 10.3, 10.9, 13.3, 10.2, to

12.4 mg/dL during the same period. Starting in December he was put on

on-line HDF because of the aggravating rheumatic symptoms. As a

result, the rheumatoid factor declined to 98 U/mL and likewise CRP

came down temporarily to 0.88 mg/dL. The knee pain and lumbar pain

were reduced and the stiffness improved during February–May 2002.

The sensitive CRP then rose to over 10 mg/dL, although the rheumatoid

factor continued declining from 98, 86, 88 to 70 U/mL. When the vol-

ume of dialysate replacement fluid was increased, CRP declined again

to 0.98 mg/dL. Observation: At our clinic, we have records of RA

26 Blood Purif 2004;22(suppl 1):1–30 General Oral Presentations

improvements by Lixelle, a �2-MG adsorption column. We confirmed

that inflammatory cytokines such as TNF-� and IL-1� were adsorbed

and removed by Lixelle. We assume that on-line HDF removed inflam-

matory cytokines as done by Lixelle, thereby achieving the improvement

of the patient’s conditions.

O-34

A Case of Cardiac Failure PatientUndergoing Maintenance Dialysis, Who Was Diagnosed as Dilated Cardiomyopathy.On-Line HDF Was Found Effective for ThisPatientY. Matsui

Matsui Clinic, Hyogo, Japan

Introduction: Cardiac failure is the most common cause of

deaths among dialysis patients, the rate reaching approximately 30%

which is extremely high by comparison to those of infectious diseases

and cerebrovascular disorders. Dialysis patients are considered as

high-risk output failure cases due to renal anemia and plethora, and

hence the need for cardiac failure treatment is high. We report our

experience with one patient for whom water purification was more

effective than water removal. Case: In this particular case, the patient

was a female age 55 with a dialysis history of 3 years. Her primary

disease was glomerular nephritis, with complications including

hypertension, cardiac failure and hyperparathyreosis. According to

medical records, she had frequently experienced difficulty in breath-

ing, palpitation and inundation on the day before dialysis starting in

June 2001. In October 2001, cardiac dilatation (cardiothoracic index

65%) and cardiac failure symptoms (New York Heart Association

classification of cardiac performance) developed, and coupled with

low blood pressure and chest pains experienced during the dialysis

therapy, made the continuation of dialysis unfeasible. In January 2002,

she was diagnosed as delated cardiomyopathy at a Cardiovascular

Medical Department, and administration of � blockers caused an

aggravated cardiac dilation and cardiac failure animus, which led to

the termination of pharmacotherapy. She was transferred to our clinic

at that point. We diagnosed her as cardiac failure caused primarily by

underdialysis of hypertensive heart although insufficient function of

left ventricular heart with cardial dilation was present and so were

conditions similar to congestive cardiomyopathy. We adopted a treat-

ment policy to administer HDF against underdialysis and protection

of cardiac muscles from ischemia. Within 9 months of transfer to our

clinic, the patient improved substantially, namely, EF of 33% to 60%,

cardiothoracic index 62% to 52%, Kt/V from 1.25 to 1.87, and

TACBUN from 58.1 (n-PCR 1.18 g/day/kg) to 37.5 (n-PCR

1.23 g/day/kg). Conclusion: Cardiac functions of the patient diag-

nosed as congestive cardiomyopathy improved successfully. The

improvement of hemodynamics and underdialysis by HDF is consid-

ered effective against chronic cardiac failure animus of maintenance

dialysis patient.

O-35

A Basic Study of Wearable Gel ModulesT. Okugawa, A.C. Yamashita

Department of Materials Science and Engineering,Shonan Institute of Technology, Kanagawa, Japan

Objective: We made a study of solute removal performance of

wearable gel modules with active charcoal dispersion. Method: We

prepared modules by dissolving 8 g of gel powder to 1,000 mL of

warmed physiological saline solution, and then adding differing

amounts of active charcoal dispersed therein. For each batch, we filled

3 acrylic tubes (25 cm long and inner diameter 6.4 cm) with perforation

at the bottom, with 300 mL each of solution and let the solution get

fixed. We made approximately 20 holes of 3 mm diameter through the

gel lengthwise to let pass test solution. We passed 700 mL of test solu-

tion containing creatinine, bromophenol blue (BPB) and vitamin B12

through the gel modules at a rate of 200 mL/min, and studied solute

removal performance. Result: When active charcoal was not added,

the gel module lost approximately 20% of each solute within 24 hours

and then the solute concentration was maintained at a more or less a sta-

ble level. When 4 g, 8 g and 12 g of active charcoal was dispersed in the

gel, the solute removal rate increased with the volume of the charcoal

dispersed. The solute removal also took place continuously and gradu-

ally for 360 hours. Conclusion: By dispersing active charcoal within

a gel, it was possible to remove solutes continuously and gradually. It

was also possible to control the solute removal rate by changing the

amount of active charcoal. We found that there is a possibility of

constructing a wearable blood purification system by combining

functional gels in multi-stages.

O-36

Impact of Operating Conditions on FilmResistance against Material TransferK. Ashimine1,2, T. Kanazashi1, H. Iguchi1, T. Ikeuchi3,K. Arai2, N. Tomisawa2, A. Takezawa2, A.C. Yamashita2

1Chuo-Rinkan Hospital, 2Department of Materials Scienceand Engineering, Shonan Institute of Technology,Kanagawa, Japan, 3Showa-University-Fujigaoka Hospital, Kanagawa, Japan

Objective: Empirical examination based on aqueous solution

systems and coefficients of mass transfer through films to study the

impact of operating conditions on film resistance against material

transfer. Method: Blood flow (QB) was varied from 200 mL/min to

300 and 400 mL/min and dialysate flow (QD) was varied from

300 mL/min to 400, 500, 600, to 700 mL/min, and creatinine clear-

ance (CL) in aqueous solution was measured to calculate the overall

mass transfer resistance. Film mass transfer resistance coefficients at

both the blood flow side and dialysate side (rB and rD) were calculated

from empirical equations. Results and Observation: When QB or

QD was increased, the clearance CL also rose, and the overall mass

transfer resistance (Ro) declined. The transfer resistance rB at the blood

side is considered unchanged when the blood flow QB is increased. So

the decline in the overall mass transfer resistance (Ro) is attributable

27Blood Purif 2004;22(suppl 1):1–309th Annual Conference of the Japanese

Society for Hemodiafiltration Therapy

mainly to the declined transfer resistance at the dialysate side (rD).

Conclusion: Setting aside internal filtration, the decline of small

molecule solute Ro is attributable mainly to the decline of dialysate

resistance. So in designing a dialyzer, the flow condition of dialysate

is a main factor to be taken into consideration.

O-37

Comparative Examination of an Acetate-Free Biofiltration and an Off-Line HDFS. Osawa, H. Yamamoto, T. Saito, Y. Kohan, S. Hisajima

Kushiro Urology Clinic, Kushiro, Japan

Objective: An acetate-free biofiltration (AFBF) is an improved

version of HDF which uses dialysate not containing acetic acid. The

system uses as a refill an isotonic sodium bicarbonate solution. We

made a comparison of performances between AFBF, which cannot cope

with a large volume replacement, and off-line HDF which makes

a large replacement possible. Method: Four male patients who were

stable maintenance dialysis patients took part in the comparison. The

dialysis duration was 4 hours. The dialysate flow rate QD was

500 mL/min and the blood flow rate QB was 300 mL/min. The dialyzer

used was BS-2.1UL. For the off-line HDF, HF-Solita was used as

a diluent, and a total of 14 L was replaced at the rate of 4.0 L/h. In the

AFBF, refill fluid for ‘BIFIL’ was used at the rate of 1.9 L/h until the

end of therapy. Result: The off-line HDF with a larger volume of

replacement was superior to the AFBF in low molecular weight protein

removal rate. The off-line HDF had a higher albumin loss, whereas the

AFBF had a higher phosphorus removal. There was no significant dif-

ference in acid-base equilibrium between the two methods after the

therapy, although there was some difference before the therapy.

Conclusion: Low molecular weight protein removal and albumin loss

were dependent on replacement volume. On the other hand, phospho-

rus removal was not dependent on replacement volume, but dependent

on the electrolyte composition of dialysate and refill fluid.

O-38

Design and Clinical Evaluation of AcetateFree On-Line HDFR. Oishi1, F. Suzuki1, T. Someya1, Y. Morimoto1, Y. Sato1,H. Ito2, H. Ogata2, E. Kinugasa2, T. Kobayashi3

Departments of 1Medical Engineering, 2Internal Medicine, Showa University Northern Yokohama Hospital,3Showa University Fujigaoka Hospital, Yokohama, Japan

Objective: We designed an AF on-line HDF system, which com-

bines an Acetate free Biofiltration (AFBF) and a pre on-line HDF. We

conducted a safety and clinical effectiveness evaluation of this system.

Subject and Method of Study: A total of 6 maintenance dialysis

patients underwent a combination of HD, AFBF, pre on-line HDF and

AF on-line HDF, using APS-15E. The removal rate of the respective

solutes, serum HCO3 before and after the therapies, acetic acid con-

centration and TMP change over time, as well as clinical symptoms

and treatments were compared.

Results:1. AF on-line HDF therapy was able to use the same volume of

sodium biocarbonate refill fluid for ‘Bifil®’ as AFBF.

2. Serum HCO3 concentration after the therapy was maintained

within an appropriate level.

3. AF on-line HDF was superior to other methods in low molecular

weight protein removal.

4. AF on-line HDF showed a rising TMP trend with passage of time.

5. There was an improvement of clinical symptoms and the treatment

frequency was reduced.

Conclusion: This treatment method made safe and effective

treatments possible with an excellent performance in low molecular

weight protein removal.

O-39

Experience of Using a Personal HDFMachine ‘INTEGRA’ Equipped with aBiofeedback SystemF. Nakagawa, H. Tsukao, K. Honda, M. Gonda, T. Kuno, Y. Nagura

Nihon University Itabashi Hospital, Tokyo, Japan

Objective: Clinical evaluation of a personal HDF machine

INTEGRA (made by Hospal), which is equipped with a biofeedback

system. Method: A total of 6 non-diabetic maintenance hemodialy-

sis patients with stable conditions underwent conventional-AFB with

a constant water removal procedure and Hemocontrol-AFB with a

biofeedback system, and they were monitored under a continuous

hemoglobin concentration surveillance by Hemoscan. The patients

underwent at least 10 sessions of each procedure and various treat-

ment parameters were recorded. Result: The %BV of patients under

therapy was monitored real time and water removal rate and dialysate

conductivity were controlled by a feedback system. Treatment param-

eters such as %BV, water removal rate, dialysate conductivity,

%BV/TWL were visualized and data stored. Overview: By using a

biofeedback system, it becomes possible to feed back information on

conditions of patients to the machine in real time, and the machine

can automatically adjust treatment parameters to meet the conditions

of the patients. By analyzing such data, it would be possible to evalu-

ate and work out the optimum choice and operation of the therapies.

28 Blood Purif 2004;22(suppl 1):1–30 General Oral Presentations

O-40

Clinical Evaluation of Profiling WaterRemoval by the Introduction of a CentralComputer Management SystemK. Otake, T. Yokouchi, T. Yamazaki, A. Kushima,Y. Yoshimoto, M. Shimazaki, T. Syuhei, H. Tokuda, H. Takada

Jinsaikai Toshima-Chuo Hospital, Tokyo, Japan

Objective: To study the clinical value of profiling water removal

based on a central computer management system. Method: A total

of 20 patients who were found in periodic blood tests to show a high

blood concentration after dialysis and who had complaints of some

kind during dialysis were chosen. They underwent 26 sessions each of

constant volume water removal and profiling water removal. During

these sessions, rate of blood pressure decline, frequency of specific

treatments, and % BV as found by crit line monitor (CLM) were

monitored and recorded. Result: By comparison to constant volume

water removal, profiling water removal increased the overall water

removal volume, but the rate of blood pressure decline and the fre-

quency of treatments made significant improvements. Also the varia-

tion in blood concentration and % BV calculated by the CLM data

were less during the profiling water removal. The value % BV/total

UF, which is % BV at the end of therapy compensated for by the

overall water removal volume, showed a significant decline in the

case of profiling water removal by comparison to constant volume

water removal. Thus by using optimum profiling patterns for individ-

ual patients, it was possible to reduce patient complaints, and to flat-

ten % BV curves. Observation: Determining a suitable plasma

refilling rate (PRR) for each patient and setting UFR in accordance

with the change of PRR over time during the dialysis therapy leads to

a stable hemodynamics and a possibility of asymptomatic dialysis by

attaining an optimum water removal pattern.