The Impact of Standard High-Flux Polysulfone Versus Novel High-Flux Polysulfone Dialysis Membranes on Inflammatory Markers: A Randomized, Single-Blinded, Controlled Clinical Trial

Abstract

This study is a prospective, randomized, single-blind, clinical trial over 12 months involving 60 stable hemodialysis patients comparing standard high-flux polysulfone dialyzer membranes with a novel high-flux polysulfone dialyzer membrane (Helixone; Fresenius Medical Care, St Wendel, Germany) modified in the fiber-spinning process to enhance middle-molecule clearance through changing the distribution of pore size and increased filtration. Markers of protein and lipid oxidation and inflammatory markers, including proinflammatory cytokines and cell adhesion molecules, were compared. The hypothesis tested was that improved clearances of middle molecules with the FX80 membrane would lead to less oxidative stress and inflammation compared with the high-flux polysulfone (HF80) membrane. Type of dialysis membrane used did not significantly affect lipid and protein peroxidation, C-reactive protein level, interleukin 6 level, or sgp130 level during 12 months. beta(2)-Microglobulin concentrations decreased significantly in the Helixone membrane group compared with those dialyzed using conventional polysulfone membranes during the study (-15%; 95% confidence interval, -20 to -10). Long-term dialysis with a Helixone membrane did not modify any parameters of oxidative stress or inflammation in this stable hemodialysis population compared with a high-flux polysulfone dialysis membrane.