Dialysate magnesium formulation of 1.5 mEq/L (0.75 mmol/L).Dialysate magnesium formulation of ≤1.0 mEq/L (≤0.5 mmol/L).
Dialysate magnesium formulation of 1.5 mEq/L (0.75 mmol/L).: (Dialysate magnesium concentration currently used in Canada and the United States)
Dialysate magnesium formulation of ≤1.0 mEq/L (≤0.5 mmol/L).: (Dialysate magnesium concentration currently used in Canada and the United States)
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion (Hemodialysis Center Level):
1. The hemodialysis center must be expected to treat at least 15 different individuals with facility-based maintenance hemodialysis over the trial period.
2. The hemodialysis center must use a system permitting the adoption of the randomly allocated dialysate Mg concentration (e.g., centers using BiCart® dialysate products, which do not include a dialysate Mg concentration of 0.75 mmol/L, were not eligible to participate).
3. The medical director, in consultation with local partners, must approve the randomization of their center and the adoption of the allocated dialysate Mg concentration as a center-wide policy for the trial period.
Primary outcome measure(s)
A composite of all-cause mortality or major cardiovascular-related hospitalizations — Four Years Data on all-cause mortality will be ascertained using provincial vital statistics databases. Major cardiovascular-related hospitalization (for myocardial infarction, ischemic stroke, or congestive heart failure) will be ascertained using most responsible diagnosis ICD-10 codes in the Canadian Institute for Health Information's Discharge Abstract Database.
Self-reported muscle cramps — Four years Self-reported muscle cramps. For self-reported muscle cramps patients will be able to voluntarily and anonymously answer a question on muscle cramps to describe on average how much this symptom bothered them in the past week. Responses will be recorded on a 11-point scale, with 0 indicating absence of the symptom and 10 indicating the symptom is at its worst. The question will be made available in the dialysis centre approximately twice a year. No patient identifiers will be collected, and this outcome will be assessed at the level of the centre. Data from the Spring 2026 collection period will be used in the primary analysis
Trial sites (1)
Facility
City
Region
Status
London Health Sciences Centre
London
Ontario
More London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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