Acute intradialytic well-being: results of a clinical trial comparing polysulfone with cuprophan. Bergamo Collaborative Dialysis Study Group.

We conducted a multicenter, randomized, double-blind, controlled clinical trial to compare the effects of a synthetic, high-flux polysulfone membrane with a standard cuprophan one on acute clinical complications during a diffusive dialysis procedure. The principal end-point, that is, the number of hypotensive episodes, was similar in polysulfone (39; 23.8%) and cuprophan (32; 19.5%). Likewise, no significant difference was found between the two membranes as far as the secondary end-point was concerned, that is, the effect on headache, nausea, pruritus and sense of well-being. We conclude that high-flux polysulfone, acutely used in standard diffusive dialysis, has no favorable influence on hypotensive episodes and does not affect some typical dialysis-related symptoms any differently from cuprophan membrane. The need is stressed for well-controlled studies specifically designed to assess the worth of new dialysis techniques and materials that may vastly raise the cost of dialysis treatment.

RCT Entities:   Population Interventions Outcomes