Survival Study in Patients Undergoing On-line Hemodiafiltration

Phase 4

Completed

• Conditions: Hemodialysis
• Interventions: Procedure: On-line hemodiafiltration; Procedure: Hemodialysis

• Registration Number: NCT00694031
• Lead Sponsor: Hospital Clinic of Barcelona

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-09
• Study First Posted: 2008-06-10
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-06
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 906

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	On-line hemodiafiltration	On-line hemodiafiltration
A	Hemodialysis	Hemodialysis

Primary Outcome Measures

Name	Time	Method
Survival	36 months

Trial Locations

Locations (2)

CSU Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain