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Randomized Controlled Trial
. 2011 Mar-Apr;24(2):196-202.
doi: 10.5301/jn.2010.386.

Design and patient characteristics of ESHOL study, a Catalonian prospective randomized study

Francisco Maduell  1 , Francesc Moreso, Mercedes Pons, Rosa Ramos, Josep Mora-Macià, Andreu Foraster, Jordi Soler, Josep M Galceran, Alberto Martinez-Castelao; Online Hemodiafiltration Study Group from the Catalonian Society of Nephrology
Collaborators, Affiliations
Randomized Controlled Trial

Design and patient characteristics of ESHOL study, a Catalonian prospective randomized study

Francisco Maduell et al. J Nephrol. 2011 Mar-Apr.

Abstract

Background: Retrospective studies showed that online hemodiafiltration (OL-HDF) is associated with a risk reduction of mortality over standard hemodialysis (HD) in patients with end-stage renal disease. Until now, no information was available from prospective randomized clinical trials.

Methods: A prospective, randomized, multicenter, open study was designed to be conducted in HD units from Catalonia (Spain). The aim of the study is to compare 3-year survival in prevalent end-stage renal disease patients randomized to OL-HDF or to continue on standard HD. The minimum sample size was calculated according to Catalonian mortality of patients on dialysis and assuming a risk reduction associated with OL-HDF of 35% (1-sided p<0.05 and a statistical power of 0.8) and a rate of dropout due to renal transplantation or loss to follow-up of 30%.

Results: From May 2007 to September 2008, 906 patients were included and randomized to OL-HDF (n=456) or standard HD (n=450). Demographics and analytical data at the time of randomization were not different between both groups of patients. Patients will be followed during a 3-year period.

Conclusion: The present study will contribute to evaluating the benefit for patient survival of OL-HDF over standard HD.

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