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ACTIVE NOT RECRUITING
NCT04079582
NA

Outcomes of a Higher vs. Lower Hemodialysate Magnesium Concentration (Dial-Mag)

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

View on ClinicalTrials.gov

Summary

Many patients on hemodialysis have low levels of magnesium. Magnesium is needed to keep the heart, kidneys, and other organs working properly. Patients with low serum magnesium concentration have a higher risk of death, heart issues, muscle cramps and fractures. There are several reasons why patients on dialysis have low levels of magnesium-these include poor diet, medication interference, and the dialysis procedure itself, which leaches small amounts of magnesium from the blood during each treatment. One way to make sure that patients on dialysis are getting enough magnesium is to increase its concentration in the dialysate. The investigator would like to do a randomized controlled trial to determine the effect of increasing the concentration of magnesium in the dialysate on the risk of people on dialysis dying or being admitted to the hospital due to heart issues. The investigator thinks increasing the magnesium in the dialysate will help patients live longer, have fewer hospitalisations related to heart disease and patients may also experience less cramping associated with dialysis. This simple adjustment to the dialysis procedure can be done at little to no cost and may even reduce overall healthcare costs. If the investigator can show that increasing magnesium in the dialysate improves patients' health, then it could become the standard of care for dialysis centres.

Official title: Outcomes of a Higher vs. Lower Hemodialysate Magnesium Concentration: A Pragmatic Cluster-randomized Clinical Trial in Hemodialysis Centres

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25000

Start Date

2022-04-04

Completion Date

2026-04

Last Updated

2026-04-17

Healthy Volunteers

No

Interventions

OTHER

Dialysate magnesium formulation of 1.5 mEq/L (0.75 mmol/L).

(Dialysate magnesium concentration currently used in Canada and the United States)

OTHER

Dialysate magnesium formulation of ≤1.0 mEq/L (≤0.5 mmol/L).

(Dialysate magnesium concentration currently used in Canada and the United States)

Locations (1)

London Health Sciences Centre

London, Ontario, Canada