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Published on: August 1, 2019
Design and patient characteristics of ESHOL study, a Catalonian prospective randomized study
Francisco Maduell1, Francesc Moreso, Mercedes Pons
1Department of Nephrology, Hospital Clínic, Barcelona, Spain.
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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