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.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001672:Biocompatible Materials; D002482:Cellulose / Q000031:analogs & derivatives*; D015926:Complement C3a / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007022:Hypotension / Q000209:etiology; D007688:Kidneys, Artificial; D008297:Male; D008567:Membranes, Artificial; D008875:Middle Aged; D011108:Polymers; D006435:Renal Dialysis / Q000009:adverse effects*; D013450:Sulfones; D001613:beta 2-Microglobulin / Q000378:metabolism
D001672:Biocompatible Materials; D008567:Membranes, Artificial; D011108:Polymers; D013450:Sulfones; D001613:beta 2-Microglobulin; C017662:polysulfone P 1700; D015926:Complement C3a; D002482:Cellulose; C009865:cuprammonium cellulose