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Completed

NCT Number: NCT01327391

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

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier Universitaire

Montpellier, 34295, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

On line Hemodiafiltration

Procedure

3 sessions/week; 3-4 hours per session

Other names: on line HDF, HDF

hemodialysis

Procedure

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

Other names: conventional hemodialysis

Primary outcomes

  1. 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 outcomes

  1. Quality of life evaluated with the KDQOL questionnaire

    Time frame: day 0, 180, 365, 730

  2. Incidence of cardiovascular events

    Time frame: day 180, 365, 730

  3. Influence of the technic on mineral metabolism disturbances

    Time frame: day 180, 365, 730

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

  4. All cause and cardiovascular mortality

    Time frame: day 180, 365, 730

  5. Influence of the technic on inflammatory parameters

    Time frame: day 180, 365, 730

    measure of pro-inflammatory cytokines and acute phase reactant proteins

  6. Influence of the technic on microbiological safety

    Time frame: day 180, 365, 730

    measure of microbiological purity of dialysate

  7. Influence of the technic on oxidative stress parameters

    Time frame: day 180, 365, 730

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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: on-line-HDF

Important dates

Study start
2005
Primary completion
2013
Study completion
2014
First posted
Apr 1, 2011
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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