Elsevier

Kidney International

Volume 50, Issue 4, October 1996, Pages 1293-1302
Kidney International

Clinical Investigation
Effects of different membranes and dialysis technologies on patient treatment tolerance and nutritional parameters

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Effects of different membranes and dialysis technologies on patient treatment tolerance and nutritional parameters. There is increasing evidence that the biochemical and cellular phenomena induced by blood/membrane/dialysate interactions contribute to dialysis-related intradialytic and long-term complications. However, there is a lack of large, prospective, randomized trials comparing biocompatible and bioincompatible membranes, and convective and diffusive treatment modalities. The primary aim of this prospective, randomized trial was to evaluate whether the use of polysulfone membrane with bicarbonate dialysate offers any advantages (in terms of treatment tolerance, nutritional parameters and pre-treatment β2-microglobulin levels) over a traditional membrane (Cuprophan®). A secondary aim was to assess whether the use of more sophisticated methods consisting of a biocompatible synthetic membrane with different hydraulic permeability at different ultrafiltration rate (highflux hemodialysis and hemodiafiltration) offers any further advantages. Seventy-one Centers were involved and stratified according to the availability of only the first two or all four of the following techniques: Cuprophan® hemodialysis (Cu-HD), low-flux polysulfone hemodialysis (LfPS-HD), high-flux polysulfone high-flux hemodialysis (HfPS-HD), and high-flux polysulfone hemodiafiltration (HfPS-HDF). The 380 eligible patients were randomized to one of the two or four treatments (132 to Cu-HD, 147 to LfPS-HD, 51 to HfPS-HD and 50 to HfPS-HDF). The follow-up was 24 months. No statistical difference was observed in the algebraic sum of the end points between bicarbonate dialysis with Cuprophan® or with low-flux polysulfone, or among the four dialysis methods under evaluation. There was a significant decrease in pre-dialysis plasma β2-microglobulin levels in high-flux dialysis of 9.04 ± 10.46 mg/liter (23%) and in hemodiafiltration of 6.35 ± 12.28 mg/liter (16%), both using high-flux polysulfone membrane in comparison with Cuprophan® and low-flux polysulfone membranes (P = 0.032). The significant decrease in pre-dialysis plasma β2-microglobulin levels could have a clinical impact when one considers that β2-microglobulin accumulation and amyloidosis are important long-term dialysis-related complications.

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Participating Centers: The Nephrology/Dialysis Departments of the following Hospitals: Lecco (Locatelli F., Marcelli D., Corti M., Pontoriero G., Di Filippo S.); Como (Rossi R., Farma R., Colantonio P., Martinelli D.); Palmanova (Vasile A., Allegra V., Mengozzi G., Martinbianco L.); Bologna S. Orsola (Bonomini V., Stefoni S., Colì L., Cianciolo G., De Sanctis L.); Lecce (Mastrangelo F., De Blasi V., Alfonso L., Rizzelli S., Patruno P.); Vicenza (La Greca G., Ronco C, Brendolan A., Crepaldi C); Alghero (Casu M.D., Mureddu S.); Brescia “Spedali Civili” (Maiorca R., Cristinelli L., Setti G., Camerini C); Firenze Careggi (Salvadori M., Bandini S., Rosati A., Mancini G.); Trieste (Panzetta G., Ianche M.); Andria (Dagostino F., Del Mastro G.); Oristano (Cogoni G., Accalai G.P., Sechi M.A.); Aosta (Alloatti S., Paternoster G., Gaiter A., Manes M.); Bari Pol. e CAL. (Schena F.P., Pertosa G., Bottalico D.); Lamezia Terme (Cantafio S., Salvo E., D'Agostino F., Guido A.); Monza (Redaelli B., Limido D., Beretta P., Viganò M.R., Dadone G.); Novara (Verzetti G., Navino C, Barbè M.C., Ruva C.E.); Prato (Amato M., Salvadori M., Aterini S., Ippolito E.); Roma Columbus (Splendiani G., Sturniolo A., Costanzi S., Passalacqua S.); Taranto (Scatizzi A., Di Maggio A., Monte-murro N.); Torino Molinette (Vercellone A., Segoloni G., Pacitti A., Maffei S.); Frosinone (Scaccia F., Fini R.); La Spezia (Bandiani G., Antiga G., Nicolini MA.); Nuoro (Asproni E., Cadinu F., Salvietti N.); San Miniato (Urti D., Lorusso P., Dani L.); Vercelli (Peona C, Filiberti O., Porcu M.C.); Voghera (Barbieri C, Costa S., Nicrosini F.); Ancona Torrette (Mioli V., Bibiano L., Carletti P.); Ancona I.N.R.C.A. (Panichi N., Melappioni M.); Bergamo (Mecca G., Mingardi G., Perticucci E.); Bolzano (Huber W., Riegler P., Giacon B.); Cagliari (Altieri P., Ferrara R., Bolasco P.G., Cabiddu G.); Casarano (Paolillo A., Morgante F.); Castelfranco Ven. (Cascone C., De Luca M.); Cerignola (De Min A.M., Capotorto M., Ungaro N., Specchio A.); Chieti (Albertazzi A., Del Rosso G., Bonomini M.); Desio (Surian M., Bonforte G., Dozio B.); Firenze S. Giovanni (Frizzi V., Ciciani A.M., Ravaglia F.); Ivrea (Giachino F., Bosticardo G.M., Francisco M.); Legnago (Biasioli S., Petrosino L.); Manduria (Chimienti S., Cristofano C., Perrone F.); Melegnano (Grassi C., Orazi E., Bisegna S., Bracchi O.); Mestre (Bazzato G., Toffoletto P.P.); Pordenone (Tesio F., Raimondi A.); Recanati (Boggi R., Campogiani V., Gentili F.); San Gavino Monreale (Bolasco F., Pistis R., Pillosu I.); S. Giovanni Rotondo (Stallone C., Aucella F.); San Severo (Procaccini D., Avanzi C.); Sassari (Sorba G., Solinas R., Cossu M.); Teramo (De Angelis S., Ripani R.); Torino G. Bosco (Piccoli G., Martina G., Quarello F.); Treviglio (Borghi M., Massazza M., Tagliaferri M.); Urbino (Pascucci M., Galiotta P., Bertolucci E.); Vimercate (Sessa A., Conte F., Serbelloni P.); Molfetta (Virgilio M., Delvino A., Conte M.); Sorgono (Mura C., Conti P., Pinna A.); Bressanone (Neumair F.); Camposampiero (Bonadonna A., Stanic L., Munaretto G.) Civitanova Marche (Ciccarelli P., Stefoni A.); Civitavecchia (Biagini M., Gerace MS., Capece R.); Fabriano (Bordoni E., Petroselli F, Scaffone V.); Fano (Lombardo V., Coppola E., Micucci G.); Fermo (Concetti M.); Macerata (Capponi E., Lisi E., Raccosta G.); Ozieri (Sanna G.M., Calvisi L., Cherchi G.L.); Tolentino (Vitali P., Castelli P., Estivi R.); Venezia (Saporiti E., De Cecco G., Lorenzi S.); Verona (Maschio G., Tessitore N., Loschiavo C.); Trento (Rovati C., Andreotti C.); Ferrara (Gilli P., De Paoli E.); Roma S. Camillo (Natili G., Pensalfini V.).

Promotion Committee: G. La Greca (Chairman, Vicenza), A. Albertazzi (Chieti), P. Altieri (Cagliari), G. Bandiani (La Spezia), G. Bellinghieri (Messina), V. Bonomini (Bologna), D. Brancaccio (Milan), U. Buoncristiani (Perugia), G. Cancarini (Brescia), G. Cannella (Genova), L. Cioni (Pisa), G. D'Amico (Milan), C. Dalla Rosa (Treviso), N. De Napoli (Cosenza), N. Di Paolo (Siena), M.G. Gentile (Milan), G. Graziani (Milan), F. Locatelli (Lecco), E. Lusvarghi (Modena), Q. Maggiore (Florence), R. Maiorca (Brescia), G. Maschio (Verona), F. Mastrangelo (Lecce), L. Minetti (Milan), V. Mioli (Ancona), G. Mioni (Udine), S. Mombelloni (Brescia), G. Panzetta (Trieste), G. Piccoli (Turin), F. Quarello (Turin), B. Redaelli (Monza), C. Ronco (Vicenza), R. Rossi (Como), F.P. Schena (Bari), G. Segoloni (Turin), P. Sorice (Naples), G. Splendiani (Rome), S. Stefoni (Bologna), A. Vercellone (Torino), G. Verzetti (Novara), C. Zoccali (Reggio Calabria), P. Zucchelli (Bologna).

Steering Committee and Trial Design: F. Locatelli (Lecco), F. Mastrangelo (Lecce), B. Redaelli (Monza), C. Ronco (Vicenza), D. Marcelli (Lecco), G. Orlandini (Palazzo Pignano)

Safety Review Committee: A. Amerio (Bari), E. Lusvarghi (Modena), L. Minetti (Milan)

Statistical Analysis: M. Comelli (Pavia), D. Marcelli (Lecco)

Randomization Center: Divisione Nefrologia e Dialisi, Ospedale di Lecco

Quality Control: B. Redaelli (Monza), F. Mastrangelo (Lecce), C. Ronco (Vicenza), D. Marcelli (Lecco), F. Locatelli (Lecco)

Data Coding and Collection: L. Scatizzi, A. Geraci (Palazzo Pignano)

Secretariat: C. D'Alessio, S. Morgano (Palazzo Pignano)

Copyright © 1996 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.