Survival Study in Patients Undergoing On-line Hemodiafiltration (ESHOL)

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 4

Conditions: Hemodialysis

Treatments: Procedure: On-line hemodiafiltration; Procedure: Hemodialysis

Study type: Interventional

Funder types: Other

Identifiers

NCT00694031

ESHOL

Details and patient eligibility

About

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.

Enrollment: 906 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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906 participants in 2 patient groups

A

Active Comparator group

Description:

Hemodialysis

Treatment:

Procedure: Hemodialysis

B

Experimental group

Description:

On-line hemodiafiltration

Treatment:

Procedure: On-line hemodiafiltration