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


CONCLUSIONS
The present study will contribute to evaluating the benefit for patient survival of OL-HDF over standard HD.
Maduell
Francisco
F
Department of Nephrology, Hospital Clínic, Barcelona, Spain.
Moreso
Francesc
F
Pons
Mercedes
M
Ramos
Rosa
R
Mora-Macià
Josep
J
Foraster
Andreu
A
Soler
Jordi
J
Galceran
Josep M
JM
Martinez-Castelao
Alberto
A
D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D017583:Hemodiafiltration; D006801:Humans; D053208:Kaplan-Meier Estimate; D007676:Kidney Failure, Chronic / Q000453:epidemiology / Q000401:mortality* / Q000628:therapy*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D006435:Renal Dialysis; D013030:Spain / Q000453:epidemiology; D015996:Survival Rate; D016896:Treatment Outcome