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

Primary Purpose

Cardiovascular Disease

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

On line Hemodiafiltration

Hemodialysis

About this trial

This is an interventional treatment trial for Cardiovascular Disease focused on measuring on line hemodiafiltration, tolerance, quality of life, cardiovascular risk, Hemodialysis patients

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept 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

Sites / Locations

Centre Hospitalier Universitaire

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

On line Hemodiafiltration

hemodialysis

Arm Description

Hemodialysis patients treated with on line hemodiafiltration technic

Hemodialysis patients treated with conventional hemodialysis technic using high flux dialyzers

Outcomes

Primary Outcome Measures

tolerance of "on line" HDF treatment versus conventional high flux hemodialysis in term of adverse events occuring during dialysis sessions

Secondary Outcome Measures

Quality of life evaluated with the KDQOL questionnaire

Incidence of cardiovascular events

Influence of the technic on mineral metabolism disturbances

measure of mineral metabolism parameters (Ca, PO4, PTH)

All cause and cardiovascular mortality

Influence of the technic on inflammatory parameters

measure of pro-inflammatory cytokines and acute phase reactant proteins

Influence of the technic on microbiological safety

measure of microbiological purity of dialysate

Influence of the technic on oxidative stress parameters

measure of oxidative stress markers (AOPP, AGE) and antioxidant systems (vitamin E)

Full Information

NCT ID

NCT01327391

First Posted

January 14, 2008

Last Updated

December 5, 2014

Sponsor

University Hospital, Montpellier

Collaborators

Ministry of Health, France

1. Study Identification

Unique Protocol Identification Number

NCT01327391

Brief Title

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

Acronym

on-line-HDF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

Collaborators

Ministry of Health, France

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Disease

Keywords

on line hemodiafiltration, tolerance, quality of life, cardiovascular risk, Hemodialysis patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

415 (Actual)

8. Arms, Groups, and Interventions

Arm Title

On line Hemodiafiltration

Arm Type

Active Comparator

Arm Description

Hemodialysis patients treated with on line hemodiafiltration technic

Arm Title

hemodialysis

Arm Type

Other

Arm Description

Hemodialysis patients treated with conventional hemodialysis technic using high flux dialyzers

Intervention Type

Procedure

Intervention Name(s)

On line Hemodiafiltration

Other Intervention Name(s)

on line HDF, HDF

Intervention Description

3 sessions/week; 3-4 hours per session

Intervention Type

Procedure

Intervention Name(s)

Hemodialysis

Other Intervention Name(s)

conventional hemodialysis

Intervention Description

3 sessions/week; 3-4 hours per session; high flux dialyzers

Primary Outcome Measure Information:

Title

tolerance of "on line" HDF treatment versus conventional high flux hemodialysis in term of adverse events occuring during dialysis sessions

Time Frame

between day 30 and day 120 of treatment

Secondary Outcome Measure Information:

Title

Quality of life evaluated with the KDQOL questionnaire

Time Frame

day 0, 180, 365, 730

Title

Incidence of cardiovascular events

Time Frame

day 180, 365, 730

Title

Influence of the technic on mineral metabolism disturbances

Description

measure of mineral metabolism parameters (Ca, PO4, PTH)

Time Frame

day 180, 365, 730

Title

All cause and cardiovascular mortality

Time Frame

day 180, 365, 730

Title

Influence of the technic on inflammatory parameters

Description

measure of pro-inflammatory cytokines and acute phase reactant proteins

Time Frame

day 180, 365, 730

Title

Influence of the technic on microbiological safety

Description

measure of microbiological purity of dialysate

Time Frame

day 180, 365, 730

Title

Influence of the technic on oxidative stress parameters

Description

measure of oxidative stress markers (AOPP, AGE) and antioxidant systems (vitamin E)

Time Frame

day 180, 365, 730

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: