NCT05339009

Brief Summary

Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) the predictive value of bio-adrenomedullin (bio-ADM) level on vascular refilling rate.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

April 13, 2022

Last Update Submit

April 13, 2022

Conditions

Chronic Kidney Disease 5D

Keywords

Chronic kidney diseaseExtracorporeal purificationBio-ADMVascular refilling rate

Outcome Measures

Primary Outcomes (1)

  • Relationship between bio-ADM level and vascular refilling rate

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

    Day 1

Secondary Outcomes (1)

  • Bio-ADM value according to comorbidity factors

    Day 1

Study Arms (1)

All patients receive conventional dialysis treatment at inclusion

All patients receive conventional dialysis treatment at inclusion

Biological: BioADM determination in plasma

Interventions

BioADM determination in plasmaBIOLOGICAL

BioADM determination in plasma

All patients receive conventional dialysis treatment at inclusion

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) for more than 1 month
  • Anuric patient

You may not qualify if:

  • Patient protected by law
  • Patient under guardianship ou curatorship
  • Patient deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Montpellier

Montpellier, France

RECRUITING

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, MD PhD

    University Hospital Center of Montpellier, FRANCE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Paul CRISTOL, MD PhD

CONTACT

+33 467 338315jp-cristol@chu-montpellier.fr

Marion MORENA CARRERE, PhD

CONTACT

+33 411 759893m-morenacarrere@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2022

First Posted

April 21, 2022

Study Start

April 1, 2022

Primary Completion

December 31, 2022

Study Completion

May 1, 2023

Last Updated

April 21, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)