Study Evaluating the Effect of Isonatremic Dialysis Treatment in Chronic Kidney Disease Patients on Dialysis (DISON-IRC)

April 13, 2022 updated by: University Hospital, Montpellier

Evaluation of the Effect of Isonatremic (vs Conventional) Dialysis Treatment on the Control of Interdialytic Weight Gain in Chronic Kidney Disease Patients on Dialysis (Stage 5D)

Aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (Stage 5D), the effect of treatment with isonatremic dialysis (vs conventional dialysis), during an observational period of 2 months each, on:

  • control of interdialytic weight gain
  • perdialytic tolerance in terms of adverse events occurring during all of the sessions of the study
  • body composition and thirst measured monthly during the 4 months of follow-up.
  • tolerance to treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34290
        • Recruiting
        • Uhmontpellier
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Farid SAIDANI, MD
        • Sub-Investigator:
          • Hélène LERAY-MORAGUES, MD
        • Sub-Investigator:
          • Cécile TURC-BARON, MD
        • Sub-Investigator:
          • Thomas BACHELET, MD, PhD
        • Sub-Investigator:
          • Franck LEROY, MD
        • Sub-Investigator:
          • Jean-Sébastien SOUWEINE, MD, PhD
        • Sub-Investigator:
          • Hadia HEBIBI, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients issued from dialysis units (hospital, clinic, non profit dialysis centers)

Description

Inclusion criteria:

  • Chronic Kidney Disease patient on dialysis (stage 5D)
  • With plasma sodium concentration between 130 and 140 mmol/L
  • Anuric
  • Patient dialysed with dialysis machine allowing isonatremic dialysis treatment

Exclusion criteria:

  • Patient with plasma sodium concentration below 130 or above 140 mmol/
  • Pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients will be receiving conventional dialysis
Patients will be receiving conventional dialysis treatment followed by isonatremic dialysis treatment during an observational period of 2 months for each treatment
Procedure: Conventional dialysis treatment
Conventional dialysis treatment
Procedure: Isonatremic dialysis treatment
Isonatremic dialysis treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of interdialytic weight gain during treatment
Time Frame: 1, 2, 3 and 4 months after inclusion
change of interdialytic weight gain during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.
1, 2, 3 and 4 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perdialytic tolerance in terms of adverse events occurring
Time Frame: 1, 2, 3 and 4 months after inclusion
Perdialytic tolerance in terms of adverse events occurring during all sessions of the study with isonatremic dialysis vs conventional dialysis for an observational period of 2 months each one.
1, 2, 3 and 4 months after inclusion
Body composition
Time Frame: 1, 2, 3 and 4 months after inclusion
Body composition monthly during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.
1, 2, 3 and 4 months after inclusion
Rate of Tolerance
Time Frame: 1, 2, 3 and 4 months after inclusion
Rate of Tolerance during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.
1, 2, 3 and 4 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Study Director: Jean-Paul CRISTOL, Prof, UH Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL20_0659

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Kidney Diseases

Clinical Trials on Conventional dialysis treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe