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Design and patient characteristics of ESHOL study, a Catalonian prospective randomized study.
MedLine Citation:
PMID:  20602331     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
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.
Authors:
Francisco Maduell; Francesc Moreso; Mercedes Pons; Rosa Ramos; Josep Mora-Macià; Andreu Foraster; Jordi Soler; Josep M Galceran; Alberto Martinez-Castelao
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of nephrology     Volume:  24     ISSN:  1724-6059     ISO Abbreviation:  J. Nephrol.     Publication Date:    2011 Mar-Apr
Date Detail:
Created Date:  2011-03-04     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9012268     Medline TA:  J Nephrol     Country:  Italy    
Other Details:
Languages:  eng     Pagination:  196-202     Citation Subset:  IM    
Affiliation:
Department of Nephrology, Hospital Clínic, Barcelona - Spain.
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