Study Evaluating the Pronostic Value of Vascular Refilling Rate on Mortality in Chronic Kidney Disease Patients on Dialysis (REMVAMIR)

April 13, 2022 updated by: University Hospital, Montpellier

Evaluation of the Pronostic Value of Vascular Refilling Rate on Mortality 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) during an observational period of 3 years:

  • the prognostic value of vascular refilling rate on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number
  • the prognostic value of interdialytic weight gain on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number
  • the prognostic value of perdialytic weight loss on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

250

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
        • Uhmontpellier

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 (non profit dialysis centers)

Description

Inclusion criteria:

  • Chronic Kidney Disease patient on dialysis (stage 5D) since at least september 2017 (3 months prior to study start date)
  • Anuric patient

Exclusion criteria:

- Chronic Kidney Disease patient on dialysis with residual kidney function

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

Cohorts and Interventions

Group / Cohort
All patients received conventional dialysis treatment
All patients received conventional dialysis treatment during an observational period of 3 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic value of vascular refilling rate on mortality
Time Frame: 2 years after inclusion
The refilling rate will be assessed by the ratio of relative blood volume
2 years after inclusion
Prognostic value of vascular refilling rate on mortality
Time Frame: 3 years after inclusion
The refilling rate will be assessed by the ratio of relative blood volume
3 years after inclusion
Prognostic value of vascular refilling rate on mortality
Time Frame: 3 years after inclusion
The refilling rate will be assessed by the ratio UF max
3 years after inclusion
Prognostic value of vascular refilling rate on mortality
Time Frame: 2 years after inclusion
The refilling rate will be assessed by the ratio UF max
2 years after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic value of interdialytic weight gain
Time Frame: 2 years after inclusion
Prognostic value of interdialytic weight gain
2 years after inclusion
Prognostic value of interdialytic weight gain
Time Frame: 3 years after inclusion
Prognostic value of interdialytic weight gain
3 years after inclusion
Prognostic value of perdialytic weight loss
Time Frame: 2 years after inclusion
Prognostic value of perdialytic weight loss
2 years after inclusion
Prognostic value of perdialytic weight loss
Time Frame: 3 years after inclusion
Prognostic value of perdialytic weight loss
3 years 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)

January 1, 2018

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

September 1, 2021

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_0660

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.

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