Tolerance of "on Line" Hemodiafiltration in Chronic Renal Failure Patients

Cardiovascular Disease Clinical Trial

— on-line-HDF  

Official title:

Tolerance of "on Line" Hemodiafiltration and Impact on Morbidity and Cardiovascular Risk Factors in Chronic Renal Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327391
• Other study ID #: UF 7753
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2008
• Last updated: December 5, 2014
• Start date: May 2005
• Est. completion date: May 2014

Study information

• Verified date: March 2011
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: May 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Procedure:
• On line Hemodiafiltration
3 sessions/week; 3-4 hours per session
• Hemodialysis
3 sessions/week; 3-4 hours per session; high flux dialyzers

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quality of life evaluated with the KDQOL questionnaire		day 0, 180, 365, 730	No
Secondary	Incidence of cardiovascular events		day 180, 365, 730	No
Secondary	Influence of the technic on mineral metabolism disturbances	measure of mineral metabolism parameters (Ca, PO4, PTH)	day 180, 365, 730	No
Secondary	All cause and cardiovascular mortality		day 180, 365, 730	No
Secondary	Influence of the technic on inflammatory parameters	measure of pro-inflammatory cytokines and acute phase reactant proteins	day 180, 365, 730	No
Secondary	Influence of the technic on microbiological safety	measure of microbiological purity of dialysate	day 180, 365, 730	No
Secondary	Influence of the technic on oxidative stress parameters	measure of oxidative stress markers (AOPP, AGE) and antioxidant systems (vitamin E)	day 180, 365, 730	No