Bio-ADM as a Biomarker of Refilling in Chronic Hemodialysis Patient (REFILBIOADM)

April 13, 2022 updated by: University Hospital, Montpellier

Bio-adrenomedullin (Bio-ADM) as a Biomarker of Refilling in Chronic Hemodialysis Patient

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • France
      • Montpellier, France
        • Recruiting
        • UH Montpellier
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Cécile UIRAUD
        • Sub-Investigator:
          • Mélodie CUNY
        • Sub-Investigator:
          • Hélène LERAY-MORAGUES
        • Sub-Investigator:
          • Cécile TURC-BARON
        • Sub-Investigator:
          • Laure PATRIER

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) for more than 1 month
  • Anuric patient

Exclusion criteria:

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

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: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All patients receive conventional dialysis treatment at inclusion
Biological: BioADM determination in plasma
BioADM determination in plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between bio-ADM level and vascular refilling rate
Time Frame: Day 1
The refilling rate will be assessed by the ratio of relative blood volume and UF max
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bio-ADM value according to comorbidity factors
Time Frame: Day 1
Bio-ADM value according to comorbidity factors (diabetes, heart failure and low-grade inflammation)
Day 1

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Jean-Paul CRISTOL, MD PhD, University Hospital Center of Montpellier, France

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)

April 1, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

April 13, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 21, 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

  • RECHMPL21_0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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