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MAGNESIR: Ionized Magnesium Balance During Hemodialysis Session

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT05337436
Collaborator
(none)
150
Enrollment
1
Location
8.3
Anticipated Duration (Months)
18
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) 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)

Condition or Disease Intervention/Treatment Phase
  • Biological: Lymphatic drainage
  • Biological: Total and ionized magnesium
  • Biological: Total and ionized calcium

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Ionized Magnesium Balance During Hemodialysis Session
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Dec 10, 2022

Arms and Interventions

Arm Intervention/Treatment
All patients receive conventional dialysis treatment at enrollment

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

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of ionized magnesium levels before and after dialysis session [day 1]

      Comparison of ionized magnesium levels before and after dialysis session

    Secondary Outcome Measures

    1. Comparison of total magnesium levels before and after dialysis session [day 1]

      Comparison of total magnesium levels before and after dialysis session

    2. Comparison of ionized calcium levels before and after dialysis session [day 1]

      Comparison of ionized calcium levels before and after dialysis session

    3. Comparison of total calcium levels before and after dialysis session [day 1]

      Comparison of total calcium levels before and after dialysis session

    4. Per-dialytic balance of ionized magnesium according to predialysis level [day 1]

      Per-dialytic balance of ionized magnesium according to predialysis level

    5. Per-dialytic balance of total magnesium according to predialysis level [day 1]

      Per-dialytic balance of total magnesium according to predialysis level

    6. Per-dialytic balance of ionized calcium according to predialysis level [day 1]

      Per-dialytic balance of ionized calcium according to predialysis level

    7. Per-dialytic balance of total calcium according to predialysis level [day 1]

      Per-dialytic balance of total calcium according to predialysis level

    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) for more than 1 month

    • Anuric patient

    Exclusion criteria:

    • Patient protected by law

    • Patient under guardianship ou curatorship

    • Patient deprived of liberty

    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, CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT05337436
    Other Study ID Numbers:
    • RECHMPL22_0004
    First Posted:
    Apr 20, 2022
    Last Update Posted:
    Apr 27, 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
    Ionized magnesium
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic
    Calcium

    Study Results

    No Results Posted as of Apr 27, 2022