Hemodialysis Clinical Trial
— ESHOLOfficial title:
A Randomized Study to Evaluate Survival in Patients Undergoing Hemodialysis or On-line Hemodiafiltration
Verified date | June 2012 |
Source | Hospital Clinic of Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Spanish Agency of Medicines |
Study type | Interventional |
Patients on hemodialysis will be randomly assigned (1:1) to continue on conventional hemodialysis or on-line hemodiafiltration, both three times per week. A 3 year follow-up and a sample size of around 750 will be necessary to detect a 35% reduction in mortality.
Status | Completed |
Enrollment | 906 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age 18 and older - Currently undergoing hemodialysis - Clinical stability - Stable vascular access Exclusion Criteria: - Chronic inflammatory diseases - Liver cirrhosis - Malignancies - Chronic immunosuppressant or antiinflammatory use - Dialysis through temporary catheter or single puncture |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinic de Barcelona | Barcelona | |
Spain | CSU Bellvitge | Hospitalet de Llobregat | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona | Societat Catalana de Nefrologia |
Spain,
Maduell F, Moreso F, Pons M, Ramos R, Mora-Macià J, Carreras J, Soler J, Torres F, Campistol JM, Martinez-Castelao A; ESHOL Study Group. High-efficiency postdilution online hemodiafiltration reduces all-cause mortality in hemodialysis patients. J Am Soc Nephrol. 2013 Feb;24(3):487-97. doi: 10.1681/ASN.2012080875. Epub 2013 Feb 14. Erratum in: J Am Soc Nephrol. 2014 May;25(5):1130. — View Citation
Maduell F, Moreso F, Pons M, Ramos R, Mora-Macià J, Foraster A, Soler J, Galceran JM, Martinez-Castelao A; Online Hemodiafiltration Study Group from the Catalonian Society of Nephrology. Design and patient characteristics of ESHOL study, a Catalonian prospective randomized study. J Nephrol. 2011 Mar-Apr;24(2):196-202. — View Citation
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---|---|---|---|---|
Primary | Survival | 36 months | No |
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