Abstract
The vitamin E-bonded polysulfone membrane hemodialyzer (ViE™-21) was evaluated in a clinical study for regulatory submission. Seventeen patients on hemodialysis were treated with conventional high-flux hemodialyzers for 2 weeks (Pre-ViE phase) and switched to the ViE-21 for 36 sessions (ViE phase) followed by an additional 2 weeks on conventional hemodialyzers (Post-ViE phase). Reduction ratios of urea, creatinine, beta-2-microglobulin, albumin, and ultrafiltration coefficients (KUF) were measured once during the Pre-ViE phase and twice during the ViE phase. Moreover, biocompatibility markers [leucocyte count, platelet count, and activated complement factor (C3a) levels] were evaluated pre-dialysis, 15 min after initiation, and post-dialysis. During the study, type and number of adverse events (AEs), and device malfunctions were recorded. ViE-21 reduction ratios and KUF were not noticeably different than those of conventional hemodialyzers. Fluctuations of leucocyte counts and C3a concentrations were similar using ViE-21 and conventional hemodialyzers; however, the platelet count fluctuation was lower in ViE-21 sessions. The frequency of episodes of hypotension occurring during the ViE phase was lower than that occurring during the Pre- and Post-ViE phases. In conclusion, this study provided performance and safety data of the ViE-21 for regulatory application. The data suggest that vitamin E-bonded hemodialyzers are beneficial in lowering platelet activation and frequency of intradialytic hypotension. Larger randomized controlled trials are needed to confirm these findings.
Highlights
Patients suffering from end-stage renal disease (ESRD) require renal replacement therapy to remove uremic toxins from their blood
Data were collected over six dialysis sessions on a conventional hemodialyzer, which was the same hemodialyzer used for routine dialysis therapy (Pre-ViE phase), and patients were switched to ViE-21 for 36 dialysis sessions (ViE phase) for further data collection
Biocompatibility was evaluated by measuring blood leucocyte and platelet counts as well as C3a concentrations in plasma
Summary
Patients suffering from end-stage renal disease (ESRD) require renal replacement therapy to remove uremic toxins from their blood. Hemodialysis, an extra-corporeal blood purification therapy using a hemodialyzer, is a well-accepted treatment for ESRD patients. Hollow fibers of cellulose were used as membrane materials for hemodialyzers. When blood components and cells come in to contact with the cellulose membrane, it causes. Another challenge of hemodialysis is to reduce oxidative stress during the extracorporeal treatments. Cardiovascular disease, chronic inflammation, and intradialytic hypotension are among the common complications in patients receiving hemodialysis, which show a causal relationship with oxidative stress [3]. Vitamin C and E are well-accepted supplements having antioxidant activities
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
