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

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.

Conditions

• Kidney Diseases
• End-Stage Kidney Disease
• Hemodialysis

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)

Sponsors & Collaborators

• ICES

  collaborator INDUSTRY

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• George & Fay Yee Centre for Health Care Innovation

  collaborator UNKNOWN

• BC Renal Agency

  collaborator UNKNOWN

• University of Calgary

  collaborator OTHER

• Alberta Health services

  collaborator OTHER

• Manitoba Centre for Health Policy

  collaborator UNKNOWN

• Ontario Renal Network

  collaborator UNKNOWN

• Queen's University

  collaborator OTHER

• The Ottawa Hospital Research Institute

  collaborator UNKNOWN

• Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease

  collaborator OTHER

• Seven Oaks Hospital Chronic Disease Innovation Centre

  collaborator NETWORK

• Alberta Strategy for Patient Oriented Research Support Unit (AbSPORU)

  collaborator UNKNOWN

• The Ontario Spor Support Unit

  collaborator OTHER

• Strategy for Patient Orientated Research

  collaborator UNKNOWN

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

  lead OTHER

Principal Investigators

• Amit X Garg, PhD, MD · ICES, Lawson, London Health Sciences Centre

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-04

Primary Completion

2026-03-31

Completion

2026-04-30

Countries

• Canada

Study Locations