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

NCT04079582 | Active Not Recruiting DMC

• 1 other identifier: R-13-999
• Study Type: interventional
• Target: 25,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dialysate Magnesium; Kidney Disease; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Cluster Randomized Controlled Trial; Muscle cramps; Cardiovascular events; Mortality; Dialysis

Outcome Measures

Primary Outcomes (2)

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

  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.

  Four Years

• Self-reported muscle cramps

  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

  Four years

Secondary Outcomes (2)

• All-cause mortality

  Four Years

• Major cardiovascular-related hospitalization

  Four years

Study Arms (2)

Higher dialysate magnesium

EXPERIMENTAL

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

Lower dialysate magnesium

ACTIVE COMPARATOR

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

Interventions

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

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

Lower dialysate magnesium

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

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

Higher dialysate magnesium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• ICES: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• George & Fay Yee Centre for Health Care Innovation: collaborator
• BC Renal Agency: collaborator
• University of Calgary: collaborator
• Alberta Health services: collaborator
• Manitoba Centre for Health Policy: collaborator
• Ontario Renal Network: collaborator
• Queen's University: collaborator
• The Ottawa Hospital Research Institute: collaborator
• Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease: collaborator
• Seven Oaks Hospital Chronic Disease Innovation Centre: collaborator
• Alberta Strategy for Patient Oriented Research Support Unit (AbSPORU): collaborator
• The Ontario Spor Support Unit: collaborator
• Strategy for Patient Orientated Research: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Location

Related Publications (1)

• Dial-Mag Investigator Writing Committee*; Killin L, Bohm C, Harris C, MacRae JM, Shah N, Thompson S, Tonelli M, Luo B, Sontrop JM, Acedillo RR, Al-Jaishi AA, Anderson S, Antonsen J, Bagga A, Beaubien E, Berry D, Blake PG, Brown PA, Bueti J, Chan CT, Cote B, Cowan AC, Cuerden MS, Day NE, Dev V, Dhruve M, Djurdjev O, Gregor L, Hiremath S, Joseph G, Kammila S, Kiaii M, Kumar Kolusu E, Lacson E Jr, Mazurat A, Molnar AO, Nathoo B, Nistico A, Oliver MJ, Pandeya S, Parmar MS, Perkins D, Quinn K, Romann A, Sasal J, Shulman T, Silver SA, Singh A, Louis IS, Steele A, Tangri N, Ting RH, Vorster H, Wadehra DB, Wald R, Walters J, Whitlock RH, Yao S, Zacharias J, Garg AX. Outcomes of Adopting a Higher Versus Lower Concentration of Hemodialysate Magnesium as a Center-Wide Policy (Dial-Mag): A Clinical Research Protocol of a Pragmatic, Registry-Based, Cluster Randomized Trial. Can J Kidney Health Dis. 2025 Dec 9;12:20543581251385011. doi: 10.1177/20543581251385011. eCollection 2025.

  PMID: 41393273 DERIVED

MeSH Terms

Conditions

Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Muscle Cramp

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Amit X Garg, PhD, MD

  ICES, Lawson, London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: April 4, 2022
• Primary Completion: March 31, 2026
• Study Completion: April 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)