Survival Study in Patients Undergoing On-line Hemodiafiltration

Hemodialysis Clinical Trial

— ESHOL  

Official title:

A Randomized Study to Evaluate Survival in Patients Undergoing Hemodialysis or On-line Hemodiafiltration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694031
• Other study ID #: ESHOL
• Status: Completed
• Phase: Phase 4
• First received: June 5, 2008
• Last updated: February 27, 2014
• Start date: May 2007
• Est. completion date: January 2012

Study information

• 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

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis

Intervention

Procedure:
• Hemodialysis
3 times per week
• On-line hemodiafiltration
3 times per week

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	CSU Bellvitge	Hospitalet de Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Societat Catalana de Nefrologia

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		36 months	No