Clinical Effectiveness of Intermittent Infusion Hemodiafiltration Using Backfiltration of Ultrapure Dialysis Fluid Compared with Predilution On-Line Hemodiafiltration

2016 ◽  
pp. 24-29
Author(s):  
Michio Mineshima ◽  
Kei Eguchi ◽  
Kanji Shishido ◽  
Susumu Takahashi ◽  
Tsukasa Kubo ◽  
...  
Keyword(s):  
Clinical Effectiveness ◽  
Intermittent Infusion ◽  
Dialysis Fluid ◽  
On Line

scholarly journals Clinical assessment of intermittent infusion hemodialysis (I-HD) using backfiltration of ultrapure dialysis fluid by an automated dialysis machine

2009 ◽  
Vol 42 (9) ◽  
pp. 695-703 ◽  
Author(s):  
Kei Eguchi ◽  
Masaki Miyao ◽  
Yushi Yamada ◽  
Yoshie Konno ◽  
Iwakazu Kaneko ◽  
...  
Keyword(s):  
Clinical Assessment ◽  
Intermittent Infusion ◽  
Dialysis Fluid

scholarly journals Expanded Hemodialysis as Effective Alternative to On-Line Hemodiafiltration: A Randomized Mid-Term Clinical Trial

2021 ◽  
Author(s):  
Fernando Hadad-Arrascue ◽  
Lars-Göran Nilsson ◽  
Angela S Rivera ◽  
Angelito A Bernardo ◽  
Juan B Cabezuelo Romero
Keyword(s):  
Clinical Effectiveness ◽  
High Volume ◽  
Attractive Alternative ◽  
Novel Therapy ◽  
Erythropoiesis Stimulating Agents ◽  
Clinical Biomarkers ◽  
Resource Needs ◽  
On Line ◽  
Fgf 23 ◽  
Controlled Clinical Study

Abstract BACKGROUND. Hemodiafiltration (HDF) enhances middle molecule (MM) removal by convection and shows survival benefit compared to high-flux hemodialysis. Expanded hemodialysis (HDx), a novel therapy that effectively clears MM, uses medium cut-off (MCO) membrane without need for replacement fluid. We aimed to compare HDx to HDF prospectively in an open randomized controlled clinical study. METHODS. In a 24-week prospective study, HDF patients (age 18–80 yrs; on HDF > 3 months) were randomized to switch to HDx (N = 21) or continue HDF (N = 22). Pre- to post-dialysis reduction ratios (RR) and changes in pre-dialysis levels over time were evaluated for MMs and other clinical biomarkers. Use of erythropoiesis-stimulating agents (ESAs) were evaluated. RESULTS. HDx showed greater RR for YKL-40 while RR appeared similar between groups for beta2-microglobulin, FGF-23, and free light chains. Intra-dialytic changes in inflammatory biomarkers (IL-6, CRP, PTX3) did not differ between therapies. Changes from baseline to 12 and 24 weeks did not differ between groups for MMs, inflammatory markers, albumin, fibrinogen, hemoglobin, PTH, and phosphorus. Usage of erythropoiesis-stimulating agents tended to decrease in HDx arm while remaining stable in HDF arm. CONCLUSIONS. HDx showed equivalent removal of MMs versus high volume HDF. Greater RR of YKL-40, predictor of cardiovascular mortality in HD, was noted in HDx group. HDx appeared safe with similar clinical effectiveness as HDF. With fewer requirements and resource needs, HDx provides an attractive alternative to HDF. Further clinical studies are needed to confirm our results. TRIAL REGISTRATION. The study was registered as NCT03499691

scholarly journals On-line Preparation of Solutions for Dialysis: Practical Aspects Versus Safety and Regulations

2002 ◽  
Vol 13 (suppl 1) ◽  
pp. S78-S83
Author(s):  
Ingrid Ledebo
Keyword(s):  
Quality Control ◽  
Information Quality ◽  
Cost Effective ◽  
Dialysis Fluid ◽  
Dialysis Therapy ◽  
Retention Capacity ◽  
Continuous Mixing ◽  
Replacement Solution ◽  
On Line ◽  
Routine Quality Control

ABSTRACT. On-line preparation, i.e., continuous mixing and immediate use, was introduced for dialysis fluid in 1964, and it contributed significantly to the expansion of dialysis therapy through simplified handling, improved microbiology, and enhanced efficiency. On-line prepared replacement solution for hemofiltration was shown to be clinically safe as early as 1978, but the implementation was delayed for 20 yr because of regulatory conservatism. On-line preparation of sterile and pyrogen-free solutions for infusion is based on the use of water and concentrates that contribute a minimum of microorganisms and are mixed and distributed in a hygienically designed and maintained flow path. Ultrafilters with known retention capacity are placed in strategic positions and dimensioned to remove bacteria and endotoxins, which gives a sterility assurance level of at least six magnitudes, as required by the Pharmacopoeia for sterile products. Microbiologic testing of the fluid should be applied when designing, validating, and troubleshooting on-line systems but not for routine quality control, because it only gives retrospective information. Quality assurance has to be built into a system and the way it is operated. On-line fluid preparation, when properly performed, is safe, simple, and cost-effective and enhances the efficiency as well as the biocompatibility of dialysis therapy.

A Clinical Significance of Intermittent Infusion Hemodiafiltration Using Backfiltration of Ultrapure Dialysis Fluid Compared to Hemodialysis: A Multicenter Randomized Controlled Crossover Trial

2019 ◽  
Vol 48 (4) ◽  
pp. 368-381
Author(s):  
Michio Mineshima ◽  
Susumu Takahashi ◽  
Tadashi Tomo ◽  
Hideki Kawanishi ◽  
Hiroshi Kawaguchi ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Treatment Period ◽  
Clinical Significance ◽  
Intermittent Infusion ◽  
Dialysis Fluid ◽  
Removal Rates ◽  
Polysulfone Membrane ◽  
Group A ◽  
The Difference ◽  
Group B

Background: Intermittent infusion hemodiafiltration ­(I-HDF) using repeated infusion of ultrapure dialysis fluid through a dialysis membrane or sterile nonpyrogenic substitution fluid was developed to prevent a rapid decrease in blood pressure by increasing the patient’s circulating blood volume, to enhance the plasma refilling rate by improving peripheral circulation, and to enhance solute transfer from the extravascular space to the intravascular space by enhancing the plasma refilling rate. Furthermore, the effect of fouling caused by attachment of proteins to the membrane as a result of ultrafiltration can be reduced by backflushing of the membrane with the purified dialysate in I-HDF. Although there have been several clinical trials of I-HDF, there have been no comparisons of the clinical significance of and indications for ­I-HDF with those of conventional hemodialysis (HD). Objective: The aim of this multicenter randomized controlled crossover trial was to compare the clinical significance of ­I-HDF with that of HD in Japan. Method: Patients were randomized to receive HD, I-HDF, and HD (group A) or I-HDF, HD, and I-HDF (group B) in that order for 14 weeks each. The sample size of 70 was determined based on the operability and patient availability. Treatment outcomes were evaluated 5 and 14 weeks after the start of each treatment period. The patients received 4-h treatment sessions with no changes in session duration or anticoagulant therapy during the study. I-HDF was performed using a GC-110N dialysis machine. Two hundred milliliters of ultrapure dialysis fluid were infused at a rate of 150 mL/min by backfiltration every 30 min during treatment. The first and last infusions were performed 30 min after the start and 30 min before the end of treatment, respectively. The total estimated infusion volume per session was 1.4 L (i.e., 200 mL × 7 infusions). I-HDF is a type of online HDF with a small fluid replacement volume. An ABH-P polysulfone membrane hemodiafilter was used for ­I-HDF and a class 1 or 2 hemodialyzer with a polysulfone membrane not coated with vitamin E and approved by the Japanese reimbursement system was used for HD. The primary outcomes were the Short Form-36 version 2 summary scores for quality of life and the visual analog scale scores for clinical symptoms. Secondary outcomes were vital signs, number of interventions, and pre-treatment blood test results. These variables were evaluated 1 week before at the start of the study, and at 5 and 14 weeks after the start of each treatment period. The removal characteristics of the various solutes were evaluated when possible on the first day of each treatment period. All patients provided written informed consent to participate. Results: Thirty-two patients in group A and 32 patients in group B completed the trial. There were no differences in the primary or secondary outcomes between I-HDF and HD. Serum α1-microglobulin (MG) levels at 14 weeks were significantly lower for I-HDF than for HD. During treatment, the removal rates for urea and creatinine, which are low molecular weight substances, were significantly lower during I-HDF than during HD. In contrast, the β2-MG and α1-MG removal rates were significantly higher during I-HDF than during HD. Furthermore, there was significantly less albumin leak during I-HDF than during HD. The solute removal results reflect the difference in pore size between the hemodiafilter used for I-HDF and the hemodialyzer used for HD and the difference in convective transport attributable to filtration between the 2 methods. Conclusions: These findings show that the removal rates of low molecular weight substances are significantly lower and those of medium to high molecular weight substances are significantly higher with I-HDF than with HD. They also indicate that there is significantly less albumin leak during I-HDF than during HD, meaning that I-HDF may be a particularly suitable dialysis modality for patients with malnutrition and the elderly in Japan.

scholarly journals Development and clinical effectiveness of intermittent infusion hemodiafiltration (I-HDF) as a new HDF therapy

2007 ◽  
Vol 40 (9) ◽  
pp. 769-774 ◽  
Author(s):  
Kei Eguchi ◽  
Norisato Ikebe ◽  
Yoshie Konno ◽  
Yushi Yamada ◽  
Iwakazu Kaneko ◽  
...  
Keyword(s):  
Clinical Effectiveness ◽  
Intermittent Infusion

Monocyte Activation and Humoral Immune Response to Endotoxins in Patients Receiving On-Line Hemodiafiltration Therapy

1998 ◽  
Vol 21 (6) ◽  
pp. 335-340 ◽  
Author(s):  
C. Weber ◽  
H.K. Stummvoll ◽  
S. Passon ◽  
D. Falkenhagen
Keyword(s):  
Microbial Contamination ◽  
Cost Effective ◽  
Dialysis Fluid ◽  
Soluble Cd14 ◽  
Humoral Immune ◽  
On Line ◽  
Continuous Filtration ◽  
Factor Α ◽  
Antibody Levels ◽  
Necrosis Factor

With the on-line preparation of substitution fluid, an easy-to-operate and cost-effective alter-native to conventional hemodiafiltration (HDF) has been realized. The continuous filtration of dialysis fluid, furthermore, allows high volumes of exchange. Microbial contamination and subsequently endotoxins, however, may be present in dialysis fluid, and thus the microbiological safety has become a pivotal issue. In this clinical study we evaluated the safety of the Fresenius Medical Care on-line HDF system which is based on a two-stage filtration of dialysis fluid with upstream DIASAFE® and downstream on-line HDF filter. During the three-month study period we failed to detect germs or endotoxins in the substitution fluid. Augmented plasma interleukin-1β (IL-1β) and tumor necrosis factor α (TNFα) concentrations were found neither during the intradialytic period nor when pre-session values at study begin and study end were compared. In addition, changes in the anti-endotoxin core antibody levels and soluble CD14 (sCD14) concentration, or pyrogenic episodes were not observed. On-line HDF with DIASAFE® and on-line HDF filter thus represents a safe treatment modality by effectively depleting dialysis fluid of cytokine-inducing substances.

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