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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05337436
Other study ID # RECHMPL22_0004
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date December 10, 2022

Study information

Verified date April 2022
Source University Hospital, Montpellier
Contact Jean-Paul CRISTOL, Prof
Phone +33(0)4 67 33 83 15
Email jp-cristol@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 10, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Biological:
Lymphatic drainage
Biological determination in plasma:
Total and ionized magnesium
Total and ionized magnesium
Total and ionized calcium
Total and ionized calcium

Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of ionized magnesium levels before and after dialysis session Comparison of ionized magnesium levels before and after dialysis session day 1
Secondary Comparison of total magnesium levels before and after dialysis session Comparison of total magnesium levels before and after dialysis session day 1
Secondary Comparison of ionized calcium levels before and after dialysis session Comparison of ionized calcium levels before and after dialysis session day 1
Secondary Comparison of total calcium levels before and after dialysis session Comparison of total calcium levels before and after dialysis session day 1
Secondary Per-dialytic balance of ionized magnesium according to predialysis level Per-dialytic balance of ionized magnesium according to predialysis level day 1
Secondary Per-dialytic balance of total magnesium according to predialysis level Per-dialytic balance of total magnesium according to predialysis level day 1
Secondary Per-dialytic balance of ionized calcium according to predialysis level Per-dialytic balance of ionized calcium according to predialysis level day 1
Secondary Per-dialytic balance of total calcium according to predialysis level Per-dialytic balance of total calcium according to predialysis level day 1
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