Ionized Magnesium Balance During Hemodialysis Session (MAGNESIR)

April 20, 2022 updated by: University Hospital, Montpellier
Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) the balance of total and ionized magnesium according to different types of dialysate used in clinical practice (acetate + Mg 0.50 or 0.75 mM vs citrate + Mg 0.50 ou 0.75 mM)

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 Locations

  • France
      • Montpellier, France, 34290
        • Recruiting
        • Uhmontpellier
        • Sub-Investigator:
          • Mélodie CUNY
        • Sub-Investigator:
          • Cécile TURC-BARON
        • Sub-Investigator:
          • Laure PATRIER
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Lotfi CHALABI
        • Sub-Investigator:
          • Cécile GUIRAUD
        • Sub-Investigator:
          • Hélène LERAY

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All patients receive conventional dialysis treatment at enrollment
Biological: Lymphatic drainage
Biological determination in plasma:
Other Names:
  • Biological determination in plasma:
Biological: Total and ionized magnesium
Total and ionized magnesium
Biological: Total and ionized calcium
Total and ionized calcium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of ionized magnesium levels before and after dialysis session
Time Frame: day 1
Comparison of ionized magnesium levels before and after dialysis session
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of total magnesium levels before and after dialysis session
Time Frame: day 1
Comparison of total magnesium levels before and after dialysis session
day 1
Comparison of ionized calcium levels before and after dialysis session
Time Frame: day 1
Comparison of ionized calcium levels before and after dialysis session
day 1
Comparison of total calcium levels before and after dialysis session
Time Frame: day 1
Comparison of total calcium levels before and after dialysis session
day 1
Per-dialytic balance of ionized magnesium according to predialysis level
Time Frame: day 1
Per-dialytic balance of ionized magnesium according to predialysis level
day 1
Per-dialytic balance of total magnesium according to predialysis level
Time Frame: day 1
Per-dialytic balance of total magnesium according to predialysis level
day 1
Per-dialytic balance of ionized calcium according to predialysis level
Time Frame: day 1
Per-dialytic balance of ionized calcium according to predialysis level
day 1
Per-dialytic balance of total calcium according to predialysis level
Time Frame: day 1
Per-dialytic balance of total calcium according to predialysis level
day 1

Collaborators and Investigators

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

Sponsor

University Hospital, 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)

April 1, 2022

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

December 10, 2022

Study Registration Dates

First Submitted

April 13, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL22_0004

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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