Efficacy and Safety of Modified Polyethersulfone Hemodialysis Filters in Comparison to Conventional Filters: A Non-inferiority Clinical Trial

Abstract

Background: The efficacy and quality of hemodialysis (HD) are closely related to the dialyzer characteristics. Objectives: This study aimed to determine the efficacy and complications of modified polyethersulfone (m-PES) -1.5 hollow fiber filters in comparison to conventional filters during HD. Methods: This non-inferiority crossover randomized clinical trial was performed in adult dialysis units at three HD centers within May 2019 to March 2020. The patients were randomly enrolled in two groups. Group A was first put on HD for six sessions with a low or high flux smart flux filter (m-PES-1.5 hollow fiber), which was made in Italy by Medica S.P.A. Group. Group B was hemodialyzed with a corresponding low or high flux filter made in Iran by Meditechsys Company. After a two-week clearance phase, the patients were dialyzed for six sessions with the opposite filter of the first six sessions. Laboratory variables, such as blood urea nitrogen and creatinine, were measured. Kt/V (i.e., a measurement of HD efficacy) and urea reduction ratio (URR) were calculated. Additionally, blood pressure was monitored. Results: A total of 40 patients were entered into the final analysis. No matter which filter was used, no statistically significant differences were observed in URR, creatinine, Kt/V, and blood pressure at different times during dialysis between the two types of filters. Packaging problems (P < 0.001) and blood clotting (P = 0.009) were two more frequent complications in the m-PES group. Conclusions: This study showed that smart flux m-PES-1.5 hollow fiber filters are similar to Meditechsys Company filters.