Nephrol Dial Transplant (2003) 18 [Suppl 7]: vii50–vii54 DOI: 10.1093/ndt/gfg1080 Convection versus diffusion in dialysis: an Italian prospective multicentre study Piergiorgio Bolasco 1 , Paolo Altieri 2 , Simeone Andrulli 3 , Carlo Basile 4 , Salvatore Di Filippo 3 , Mariano Feriani 5 , Luciano Pedrini 6 , Antonio Santoro 7 , Carmine Zoccali 8 , Giovanna Sau 2 and Francesco Locatelli 3 Departments of Nephrology and Dialysis, 1 Unita` Operativa: Servizio Dialisi Territoriale, Azienda USL N.8 di Cagliari, 2 Dipartimento Malattie Renali, Azienda Ospedaliera G. Brotzu, Cagliari, 3 Divisione Nefrologia e Dialisi, Azienda Ospedaliera ‘Ospedale di Lecco’, Lecco, 4 Divisione Nefrologia ‘Ospedale di Martina Franca’, Martina Franca, 5 Reparto di Nefrologia e Dialisi, Ospedale Umberto I  Mestre, Venezia, 6 Divisione Nefrologia e Dialisi, Ospedale Bolognini, Seriate, 7 Unita` Operativa Nefrologia e Dialisi Malpighi, Policlinico S. Orsola-Malpighi, Bologna and 8 CNR-IBM Epidemiologia Clinica e Fisiopatologia Malattie Renali e Ipertensione Arteriosa, Unita` Operativa Nefrologia Dialisi e Trapianto Renale, Reggio Calabria, Italy Steering committee: Chairmen: Francesco Locatelli and Paolo Altieri; Members: Simeone Andrulli, Carlo Basile, Piergiorgio Bolasco, Salvatore di Filippo, Mariano Feriani, Luciano Pedrini, Antonio Santoro and Carmine Zoccali . Trial design: Francesco Locatelli, Paolo Altieri, Piergiorgio Bolasco and Simeone Andrulli Statistical analysis: Simeone Andrulli Database and clinical record forms: Simeone Andrulli, Piergiorgio Bolasco and Salvatore Di Filippo Clinical monitoring and data collection: Piergiorgio Bolasco, Simeone Andrulli and Giovanna Sau Quality control: Carmine Zoccali, Antonio Santoro, Mariano Feriani, Luciano Pedrini, Carlo Basile, Salvatore Di Filippo, Francesco Pizzarelli, Vincenzo Savica and Salvatore David. Abstract The conceptofdialysisadequacyhastobewidenedto include medium size and large molecule removal in addition to urea kinetics. The HEMO study found a non-significant trend toward a beneficial effect on mortality of high-flux dialysis compared with low-flux dialysis. In that study, the beneficial effect of convection could have been attenuated by the fact that ‘internal filtration’ in high-flux haemodialysis (HD) is lower than that expected by convection in haemofiltration(HF)orhaemodiafiltration(HDF).To exploretheputativebeneficialeffectofconvection,this Italian multicentre study was planned, comparing on-line convective treatments (HF and HDF) with standard, low-flux HD. The enrolled patients will be evaluated prospectively on their usual treatment for 2 months(baselineperiod)andsubsequentlyrandomized to continue either with low-flux HD (50%) or to start on-line convective treatment (50%), HF or HDF according to a 1:1 ratio. The primary end point of the study will be cardiovascular stability and blood pressure control. As secondary aims of the study, the impact on symptoms, morbidity and mortality will be assessed. Feasibility and patient compliance during HF and HDF treatments will also be evaluated. The experimental phase of the study, of at least 2 years, is divided into a 3-month adaptation period and a subsequent evaluation period. A recruitment period of 1yearisplanned.Thestudydesignhasadequatepower to detect an absolute reduction of 3% hypotensive episodes with the experimental convective treatments compared with standard low-flux HD. Keywords: blood pressure; cardiovascular stability; morbidity; mortality; symptomatic hypotension Study background and rationale Over the last decade, several epidemiological studies based on large databases have suggested a possible superiority of convective treatments in terms of reducing morbidity and mortality of dialysis patients Correspondence and offprint requests to: Dr Piergiorgio Bolasco, Unita` Operativa Servizio Dialisi Territoriale, Azienda USL N.8 di Cagliari, Via Turati 4/C, 09045 Quartu Sant’Elena, Cagliari, Italy. Email: dialisiterritorio@tiscali.it ß 2003 European Renal Association–European Dialysis and Transplant Association Downloaded from https://academic.oup.com/ndt/article/18/suppl_7/vii50/1818292 by guest on 21 June 2022