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

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04810338
Collaborator
(none)
250
Enrollment
1
Location
44
Actual Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

  1. 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.
Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Evaluation of the Pronostic Value of Vascular Refilling Rate on Mortality in Chronic Kidney Disease Patients on Dialysis (Stage 5D)
    Actual Study Start Date :
    Jan 1, 2018
    Actual Primary Completion Date :
    Dec 1, 2020
    Actual Study Completion Date :
    Sep 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    All patients received conventional dialysis treatment

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

    Outcome Measures

    Primary Outcome Measures

    1. Prognostic value of vascular refilling rate on mortality [2 years after inclusion]

      The refilling rate will be assessed by the ratio of relative blood volume

    2. Prognostic value of vascular refilling rate on mortality [3 years after inclusion]

      The refilling rate will be assessed by the ratio of relative blood volume

    3. Prognostic value of vascular refilling rate on mortality [3 years after inclusion]

      The refilling rate will be assessed by the ratio UF max

    4. Prognostic value of vascular refilling rate on mortality [2 years after inclusion]

      The refilling rate will be assessed by the ratio UF max

    Secondary Outcome Measures

    1. Prognostic value of interdialytic weight gain [2 years after inclusion]

      Prognostic value of interdialytic weight gain

    2. Prognostic value of interdialytic weight gain [3 years after inclusion]

      Prognostic value of interdialytic weight gain

    3. Prognostic value of perdialytic weight loss [2 years after inclusion]

      Prognostic value of perdialytic weight loss

    4. Prognostic value of perdialytic weight loss [3 years after inclusion]

      Prognostic value of perdialytic weight loss

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34290

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04810338
    Other Study ID Numbers:
    • RECHMPL20_0660
    First Posted:
    Mar 22, 2021
    Last Update Posted:
    Apr 14, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Chronic Kidney Disease patient on dialysis (stage 5D)
    Extracorporeal purification
    Sodium
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic

    Study Results

    No Results Posted as of Apr 14, 2022