Design and Patient Characteristics of ESHOL Study, a Catalonian Prospective Randomized Study

J Nephrol. Mar-Apr 2011;24(2):196-202. doi: 10.5301/jn.2010.386.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Female
  • Follow-Up Studies
  • Hemodiafiltration*
  • Humans
  • Kaplan-Meier Estimate
  • Kidney Failure, Chronic / epidemiology
  • Kidney Failure, Chronic / mortality*
  • Kidney Failure, Chronic / therapy*
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Prospective Studies
  • Renal Dialysis*
  • Spain / epidemiology
  • Survival Rate
  • Treatment Outcome