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
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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.
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