Comparative Biocompatibility of Polysulfone Hemodialysers Applied in Different Treatment Modalities
- Conditions
- N18.5Chronic kidney disease, stage 5
- Registration Number
- DRKS00008200
- Lead Sponsor
- Fresenius Medical Care Deutschland GmbH
- Brief Summary
Background: The hemocompatibility of dialyzers for extracorporeal kidney replacement therapy (KRT) is of importance to minimize harmful reactions between blood constituents and the membrane. We investigated in these exploratory studies the hemocompatibility profile of several types of polysulfone dialyzers. Methods: Hemocompatibility of various high-flux polysulfone dialyzers were compared in two consecutive, prospective, randomized, crossover studies, each including 24 adult patients being at least 3 months on hemodialysis (HD) or on-line hemodiafiltration (HDF). These dialyzers, differing in membrane type, fiber geometry, sterilization method, and production technology, were each applied for 1 week in HD or HDF. Hemocompatibility was assessed through markers of complement activation, cell activation, coagulation, contact activation, and immunologic reactions. Results: The patients in the two studies were on average 67±11 and 68±11 years old, 75% and 67% were male, and were on KRT for 5.4±5.0 and 4.4±3.6 years. The complement factors C3a and C5a increased early and transiently during treatment, less so with HDF than with HD, and with dialyzers combining wider inner fiber diameter (210 versus 185 µm) and advanced membrane type (Helixone plus versus Helixone). sC5b-9 increased in all study phases, reaching its highest level after 60 minutes, with lower values over the entire treatment (area under the curve) for HDF than HD, and for wider inner fiber diameter and advanced membrane type. Leukocytes decreased in the first 10 minutes, without significant differences between dialyzers. PMN elastase increased in the first hour, more so with HD than HDF. Thrombocytes decreased slightly in the first 30 minutes, with differences only between HDF and HD mode. IL-8 decreased from pre- to postdialysis, particularly on HDF. No differences were observed for kallikrein, IgE, and hsCRP. Conclusions: In these explorative studies we found indications to a comparable hemocompatibility profile of the investigated dialyzers. We observed distinctions in compounds between HDF and HD and for some dialyzer and membrane characteristics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
General:
•Minimum age of 18 years
•Informed consent signed and dated by study patient and investigator/authorised physician
•Ability to understand the nature and requirements of the study
Study-specific:
•On maintenance high-flux hemodialysis or on-line hemodiafiltration (three times/week) for = 3 months, at least 4 h treatment time
•Vascular access (fistula or graft) which enables suitable effective blood flow rate (= 300 ml/min)
General:
•Any condition which could interfere with the patient’s ability to comply with the study
•Ongoing participation in an interventional clinical study or during the preceding 30 days
•Previous participation in this study
•(in case of female patients:) Pregnancy or lactation period
Study-specific:
•Recurrent episodes of vascular access failure
•Single needle treatments
•Catheter as vascular access
•Instable patients (due to e.g. acute intercurrent disease like cardiovascular infarction, active malignant disease)
•Patients with NYHA =3, COPD, frequent intradialytic hypotension
•Patients with known or suspected allergy to trial product, related products or with other allergies, or on antiallergic medication
•Planned absence from dialysis unit within the next 3 weeks e.g. due to scheduled hospitalisation/holidays
•Active HBV, HCV, HIV infection
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Due to the explorative nature of this study no explicit primary variable has been defined. Instead, the analysis of a set of laboratory parameters shall provide a typical profile indicative of biocompatibility of the hemodialyser, and possible impact by treatment modality, respectively.<br>These factors are: Factors of complement activation, Markers of cell activation, Inflammatory and other markers.<br>
- Secondary Outcome Measures
Name Time Method Safety variables: Electrolytes, Blood gas analysis, Adverse events<br>