Kidney disease places a heavy burden on patients, their families and caregivers, and the health care system. For persons whose kidneys have failed, dialysis represents a treatment that can prolong life.
Dialysate, the fluid used in dialysis, is a critical component of the treatment, yet little evidence is available to guide its optimal formulation. In particular, the concentration of magnesium in dialysis has received little scientific attention until recently, with new research suggesting that a higher dialysate magnesium concentration may benefit patients.
Magnesium is an essential element that supports heart, muscle, and bone health. During dialysis, some magnesium is removed from the blood, but dialysate has magnesium added to replace the magnesium removed during the dialysis process. The concentrations of magnesium in dialysate can vary depending upon the manufacturer and the prescribing physician’s orders. In prior smaller trials lower serum concentrations of magnesium have associated with a higher risk of cardiovascular disease, muscle cramps, and fractures.
The Dialysate Magnesium (Dial-Mag) Trial is a large-scale randomized pragmatic clinical trial focused on determining whether different concentrations of magnesium in dialysate is associated with improved outcomes for dialysis patients. It is currently running in four provinces in over 140 hemodialysis centres. Through this trial, we hope to determine the optimal concentration of dialysate magnesium for patient health.
Dial-Mag is designed to be embedded into routine hemodialysis care. The allocated therapy will be supplied to the unit with no alterations to existing treatment, or additional patient visits. Also, most of the data collected during the trial is already routinely collected as a part of standard health care practice. As a result, the implementation of Dial-Mag creates very few, if any, disruptions to the workflow of ongoing healthcare to dialysis patients.
The hemodialysis centres were randomized into two groups: the first will administer a dialysate magnesium concentration of less than or equal to 0.5 mmol/L, and the second will administer a dialysate magnesium concentration of 0.75 mmol/L. During the trial participating centres will provide the same dialysate magnesium concentration to patients receiving care in the centre, and the patients’ health outcomes will be gathered throughout the duration of the trial. We hope to report the results by Fall 2027 and anticipate we will include more than 8 million hemodialysis sessions during the trial period