Active — Not RecruitingNot Applicable

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

Canada25,000 participantsStarted 2022-04-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

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Inclusion criteria

. The hemodialysis center must be expected to treat at least 15 different individuals with facility-based maintenance hemodialysis over the trial period.
. 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).
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

A composite of all-cause mortality or major cardiovascular-related hospitalizations

Timeframe: Four Years

Self-reported muscle cramps

Timeframe: Four years

Trial details

NCT IDNCT04079582

SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-31

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