Tolerance of "on Line" Hemodiafiltration in Chronic Renal Failure Patients (on-line-HDF)

University Hospital Center (CHU)

Status and phase: Completed; Phase 4

Conditions: Cardiovascular Disease

Treatments: Procedure: Hemodialysis; Procedure: On line Hemodiafiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT01327391

UF 7753

Details and patient eligibility

About

The aim of this study is to appreciate the tolerance of "on line" hemodiafiltration and its impact on morbidity and cardiovascular risk factors in chronic renal failure patient.

Full description

The aim of this study is to appreciate the tolerance of "on line" HDF treatment versus conventional high flux hemodialysis in term of adverse events occuring during dialysis sessions between day 30 and day 120 of treatment and to evaluate:

• Quality of life evaluated with the KDQOL questionnaire
• Incidence of cardiovascular events
• Influence of the technic on cardiovascular, inflammatory and infectious risk factors
• Mortality

Enrollment: 415 patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient who has signed the written consent form
• Patient aged > 65 and < 90 years
• With creatinine clearance < 10 mL/min
• On dialysis for a minimum of 3 months, with 3 times a week hemodialysis sessions
• Erythropoietin dosage needed to maintain hemoglobin at a constant level (range of hemoglobin: 9-13 g/dL without any variation of more than 2g/dL for less than 3 months)
• Without any problem of vascular access

Exclusion criteria

• Patient aged < 65 and > 90 years
• Presence of severe malnutrition (albumin < 20 g/L)
• Unstable clinical condition
• Unipuncture or failed vascular access flow
• Known problems of coagulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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415 participants in 2 patient groups

On line Hemodiafiltration

Active Comparator group

Description:

Hemodialysis patients treated with on line hemodiafiltration technic

Treatment:

Procedure: On line Hemodiafiltration

hemodialysis

Other group

Description:

Hemodialysis patients treated with conventional hemodialysis technic using high flux dialyzers

Treatment:

Procedure: Hemodialysis