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Nephrol Dial Transplant (2003) 18: VII50-VII54
© 2003 European Renal Association-European Dialysis and Transplant Association

Convection versus diffusion in dialysis: an Italian prospective multicentre study

Piergiorgio Bolasco1, Paolo Altieri2, Simeone Andrulli3, Carlo Basile4, Salvatore Di Filippo3, Mariano Feriani5, Luciano Pedrini6, Antonio Santoro7, Carmine Zoccali8, Giovanna Sau2 and Francesco Locatelli3

Departments of Nephrology and Dialysis, 1 Unità 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 Unità Operativa Nefrologia e Dialisi Malpighi, Policlinico S. Orsola-Malpighi, Bologna and 8 CNR-IBM Epidemiologia Clinica e Fisiopatologia Malattie Renali e Ipertensione Arteriosa, Unità Operativa Nefrologia Dialisi e Trapianto Renale, Reggio Calabria, Italy

Correspondence and offprint requests to: Dr Piergiorgio Bolasco, Unità Operativa Servizio Dialisi Territoriale, Azienda USL N.8 di Cagliari, Via Turati 4/C, 09045 Quartu Sant’Elena, Cagliari, Italy. Email: dialisiterritorio{at}tiscali.it

Abstract

The concept of dialysis adequacy has to be widened to 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) or haemodiafiltration (HDF). To explore the putative beneficial effect of convection, 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 (baseline period) and subsequently randomized 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 1 year is planned. The study design has adequate power 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

Notes

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.


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