NCT04810338

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

2.9 years

First QC Date

March 17, 2021

Last Update Submit

April 13, 2022

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney Disease patient on dialysis (stage 5D)Extracorporeal purificationSodium

Outcome Measures

Primary Outcomes (4)

  • Prognostic value of vascular refilling rate on mortality

    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

    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

    The refilling rate will be assessed by the ratio UF max

    3 years after inclusion

  • Prognostic value of vascular refilling rate on mortality

    The refilling rate will be assessed by the ratio UF max

    2 years after inclusion

Secondary Outcomes (4)

  • Prognostic value of interdialytic weight gain

    2 years after inclusion

  • Prognostic value of interdialytic weight gain

    3 years after inclusion

  • Prognostic value of perdialytic weight loss

    2 years after inclusion

  • Prognostic value of perdialytic weight loss

    3 years after inclusion

Study Arms (1)

All patients received conventional dialysis treatment

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients issued from dialysis units (non profit dialysis centers)

You may qualify if:

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

You may not qualify if:

  • \- Chronic Kidney Disease patient on dialysis with residual kidney function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34290, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Paul CRISTOL, Prof

    UH MONTPELLIER

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 22, 2021

Study Start

January 1, 2018

Primary Completion

December 1, 2020

Study Completion

September 1, 2021

Last Updated

April 14, 2022

Record last verified: 2022-04

Locations

FR(1)