Estimated influence of a novel biocompatible dialysis membrane on vascular events in dialysis patients with diabetic nephropathy: a prospective randomized controlled pilot study

Abstract

Background Polysulfone (PS) dialyzers are most frequently used worldwide for chronic renal failure patients and they are produced by several manufacturers. Despite using the same materials, differences in biocompatibility among PS dialyzers have been reported. TORAYLIGHT NV (NV) is a PS dialyzer that was reported to have superior biocompatibility compared with other PS membranes (conventional PS membranes). Therefore, we examined whether biocompatibility of PS membranes would affect the occurrence of cardiovascular events in hemodialysis patients with diabetic nephropathy (DN). Methods Fifty hemodialysis patients with DN were enrolled. They were randomly divided into NV and PS groups and then followed up for 3 years. The number of patients who developed cardiovascular events and clinical data including laboratory tests and blood pressure was recorded. Results There were 13 and 14 patients who developed cardiovascular events during the 3-year follow-up of the NV and PS groups, respectively. There was no significant difference between the groups. There were no significant differences in most of the clinical data between the two groups. However, serum pentosidine concentrations in the PS group significantly increased throughout this study, while those in the NV group did not change. Additionally, the width of the systolic blood pressure drop, which was shown to be the difference between before and after dialysis session, in the PS group showed no change, while that in the NV group tended to decrease. Conclusions The superiority of using NV membrane compared with conventional PS membranes in reducing cardiovascular events in hemodialysis patients with DN remains unclear. However, our results suggested that PS membranes with superior biocompatibility would slow the progression of atherosclerosis and reduce the occurrence of intradialytic hypotension. Trial registration This study was retrospectively registered with the Clinical Trials Registry at the University Hospital Medical Information Network (UMIN-CTR) on March 17, 2017 (registration ID, UMIN 000026339). https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000030259&type=summary&language=J