. 2025 Dec 9:12:20543581251385011.

doi: 10.1177/20543581251385011. eCollection 2025.

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

Dial-Mag Investigator Writing Committee*; Lauren Killin¹, Clara Bohm², Claire Harris³, Jennifer M MacRae⁴, Nikhil Shah⁵, Stephanie Thompson⁵, Marcello Tonelli^{6

7}, Bin Luo^{1

8}, Jessica M Sontrop^{1

9}, Rey R Acedillo¹⁰, Ahmed A Al-Jaishi¹¹, Sierra Anderson¹², John Antonsen^{13

14}, Amit Bagga¹⁵, Eliot Beaubien¹⁶, David Berry¹⁷, Peter G Blake^{18

19}, Pierre A Brown²⁰, Joe Bueti^{21

22}, Christopher T Chan²³, Brenden Cote²⁴, Andrea C Cowan²⁵, Meaghan S Cuerden¹, Nicole E Day¹, Varun Dev²⁶, Miten Dhruve²⁷, Ognjenka Djurdjev¹⁴, Laura Gregor²⁸, Swapnil Hiremath²⁹, Geena Joseph³⁰, Srinu Kammila³¹, Mercedeh Kiaii³², Eswar Kumar Kolusu¹, Eduardo Lacson Jr³³, Andrea Mazurat³⁴, Amber O Molnar^{35

36}, Bharat Nathoo³⁷, Amy Nistico³⁸, Matthew J Oliver³⁹, Sanjay Pandeya⁴⁰, Malvinder S Parmar^{41

42}, David Perkins⁴³, Kathleen Quinn⁴⁴, Alexandra Romann¹⁴, Joanna Sasal⁴⁵, Tanya Shulman⁴⁶, Samuel A Silver⁴⁷, Anurag Singh⁴⁸, Irina St Louis¹, Andrew Steele⁴⁹, Navdeep Tangri⁵⁰, Robert H Ting⁵¹, Hans Vorster⁵², Davinder B Wadehra⁵³, Ron Wald⁵⁴, Justin Walters⁵⁵, Reid H Whitlock⁵⁰, Shaoyee Yao⁵⁶, James Zacharias^{57

58}, Amit X Garg^{1

9

23

59}

Affiliations

¹ London Health Sciences Centre and London Health Sciences Centre Research Institute, ON, Canada.
² Division of Nephrology, Max Rady College of Medicine, University of Manitoba, Winnipeg, Canada.
³ Division of Nephrology, Department of Medicine, Vancouver General Hospital, The University of British Columbia, Vancouver, Canada.
⁴ Cummings School of Medicine, University of Calgary, AB, Canada.
⁵ Division of Nephrology, Department of Medicine, University of Alberta Hospital, University of Alberta, Edmonton, Canada.
⁶ Department of Medicine, University of Calgary, AB, Canada.
⁷ Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, AB, Canada.
⁸ ICES, Toronto, ON, Canada.
⁹ Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
¹⁰ Department of Medicine, Thunder Bay Regional Health Sciences Centre, ON, Canada.
¹¹ Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
¹² London Health Sciences Centre Research Institute, London Health Sciences Centre, ON, Canada.
¹³ Division of Nephrology, The University of British Columbia, Vancouver, Canada.
¹⁴ BC Renal, Vancouver, Canada.
¹⁵ Windsor Regional Hospital, ON, Canada.
¹⁶ Dialysis Management Clinics, Peterborough, ON, Canada.
¹⁷ Sault Area Hospital, Sault Ste. Marie, ON, Canada.
¹⁸ Division of Nephrology, Western University, London, ON, Canada.
¹⁹ Ontario Renal Network, Ontario Health, Toronto, Canada.
²⁰ Department of Medicine, The Ottawa Hospital Research Institute, University of Ottawa, ON, Canada.
²¹ Health Sciences Centre, Winnipeg, MB, Canada.
²² Section of Nephrology, Department of Internal Medicine, University of Manitoba, Winnipeg, Canada.
²³ Department of Medicine, Division of Nephrology, University Health Network, University of Toronto, ON, Canada.
²⁴ Patient Partner, London Health Sciences Centre, ON, Canada.
²⁵ Division of Nephrology, Department of Medicine, Western University, London, ON, Canada.
²⁶ Humber River Hospital, Toronto, ON, Canada.
²⁷ Division of Nephrology, Michael Garron Hospital, Toronto, ON, Canada.
²⁸ Grand River Hospital, Kitchener, ON, Canada.
²⁹ Department of Medicine, University of Ottawa, ON, Canada.
³⁰ Renfrew Victoria Hospital, ON, Canada.
³¹ Peterborough Regional Health Centre, ON, Canada.
³² Division of Nephrology, Department of Medicine, St. Paul's Hospital, Vancouver, BC, Canada.
³³ Division of Nephrology, Tufts University School of Medicine, Boston, MA, USA.
³⁴ Manitoba Renal Program, Seven Oaks, Canada.
³⁵ St. Joseph's Healthcare Hamilton, ON, Canada.
³⁶ Division of Nephrology, Department of Medicine, McMaster University, Hamilton, ON, Canada.
³⁷ Mackenzie Health, Richmond Hill, ON, Canada.
³⁸ Health Sciences North, Sudbury, ON, Canada.
³⁹ Division of Nephrology, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, ON, Canada.
⁴⁰ Halton Healthcare, Oakville, ON, Canada.
⁴¹ Department of Medicine, Timmins and District Hospital, ON, Canada.
⁴² Northern Ontario School of Medicine-East Campus, Clinical Sciences, Sudbury, ON, Canada.
⁴³ Trillium Health Partners, Mississauga, ON, Canada.
⁴⁴ Niagara Health System, St. Catharines, ON, Canada.
⁴⁵ St. Joseph's Health Centre, Toronto, ON, Canada.
⁴⁶ North Bay Regional Health Centre, ON, Canada.
⁴⁷ Division of Nephrology, Kingston Health Sciences Center, Queen's University, Kingston, ON, Canada.
⁴⁸ Division of Nephrology, University Hospital of Northern British Columbia, Prince George, Canada.
⁴⁹ Lakeridge Health, Whitby, ON, Canada.
⁵⁰ Chronic Disease Innovation Centre, Seven Oaks Hospital, Winnipeg, MB, Canada.
⁵¹ Division of Medicine, Scarborough Health Network, ON, Canada.
⁵² Can-SOLVE CKD Network, Vancouver, BC, Canada.
⁵³ William Osler Health System, Etobicoke, ON, Canada.
⁵⁴ Division of Nephrology, St. Michael's Hospital, University of Toronto, ON, Canada.
⁵⁵ Manitoba Renal Program, St. Boniface, MB, Canada.
⁵⁶ Fraser East Nephrology Associates, Abbotsford, BC, Canada.
⁵⁷ Division of Internal Medicine, Health Sciences Centre, Winnipeg, MB, Canada.
⁵⁸ Department of Internal Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada.
⁵⁹ Victoria Hospital, London Health Sciences Centre, ON, Canada.

PMID: 41393273
PMCID: PMC12696322
DOI: 10.1177/20543581251385011

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

Dial-Mag Investigator Writing Committee* et al. Can J Kidney Health Dis. 2025.

. 2025 Dec 9:12:20543581251385011.

doi: 10.1177/20543581251385011. eCollection 2025.

Authors

Affiliations

¹ London Health Sciences Centre and London Health Sciences Centre Research Institute, ON, Canada.
² Division of Nephrology, Max Rady College of Medicine, University of Manitoba, Winnipeg, Canada.
³ Division of Nephrology, Department of Medicine, Vancouver General Hospital, The University of British Columbia, Vancouver, Canada.
⁴ Cummings School of Medicine, University of Calgary, AB, Canada.
⁵ Division of Nephrology, Department of Medicine, University of Alberta Hospital, University of Alberta, Edmonton, Canada.
⁶ Department of Medicine, University of Calgary, AB, Canada.
⁷ Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, AB, Canada.
⁸ ICES, Toronto, ON, Canada.
⁹ Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
¹⁰ Department of Medicine, Thunder Bay Regional Health Sciences Centre, ON, Canada.
¹¹ Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
¹² London Health Sciences Centre Research Institute, London Health Sciences Centre, ON, Canada.
¹³ Division of Nephrology, The University of British Columbia, Vancouver, Canada.
¹⁴ BC Renal, Vancouver, Canada.
¹⁵ Windsor Regional Hospital, ON, Canada.
¹⁶ Dialysis Management Clinics, Peterborough, ON, Canada.
¹⁷ Sault Area Hospital, Sault Ste. Marie, ON, Canada.
¹⁸ Division of Nephrology, Western University, London, ON, Canada.
¹⁹ Ontario Renal Network, Ontario Health, Toronto, Canada.
²⁰ Department of Medicine, The Ottawa Hospital Research Institute, University of Ottawa, ON, Canada.
²¹ Health Sciences Centre, Winnipeg, MB, Canada.
²² Section of Nephrology, Department of Internal Medicine, University of Manitoba, Winnipeg, Canada.
²³ Department of Medicine, Division of Nephrology, University Health Network, University of Toronto, ON, Canada.
²⁴ Patient Partner, London Health Sciences Centre, ON, Canada.
²⁵ Division of Nephrology, Department of Medicine, Western University, London, ON, Canada.
²⁶ Humber River Hospital, Toronto, ON, Canada.
²⁷ Division of Nephrology, Michael Garron Hospital, Toronto, ON, Canada.
²⁸ Grand River Hospital, Kitchener, ON, Canada.
²⁹ Department of Medicine, University of Ottawa, ON, Canada.
³⁰ Renfrew Victoria Hospital, ON, Canada.
³¹ Peterborough Regional Health Centre, ON, Canada.
³² Division of Nephrology, Department of Medicine, St. Paul's Hospital, Vancouver, BC, Canada.
³³ Division of Nephrology, Tufts University School of Medicine, Boston, MA, USA.
³⁴ Manitoba Renal Program, Seven Oaks, Canada.
³⁵ St. Joseph's Healthcare Hamilton, ON, Canada.
³⁶ Division of Nephrology, Department of Medicine, McMaster University, Hamilton, ON, Canada.
³⁷ Mackenzie Health, Richmond Hill, ON, Canada.
³⁸ Health Sciences North, Sudbury, ON, Canada.
³⁹ Division of Nephrology, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, ON, Canada.
⁴⁰ Halton Healthcare, Oakville, ON, Canada.
⁴¹ Department of Medicine, Timmins and District Hospital, ON, Canada.
⁴² Northern Ontario School of Medicine-East Campus, Clinical Sciences, Sudbury, ON, Canada.
⁴³ Trillium Health Partners, Mississauga, ON, Canada.
⁴⁴ Niagara Health System, St. Catharines, ON, Canada.
⁴⁵ St. Joseph's Health Centre, Toronto, ON, Canada.
⁴⁶ North Bay Regional Health Centre, ON, Canada.
⁴⁷ Division of Nephrology, Kingston Health Sciences Center, Queen's University, Kingston, ON, Canada.
⁴⁸ Division of Nephrology, University Hospital of Northern British Columbia, Prince George, Canada.
⁴⁹ Lakeridge Health, Whitby, ON, Canada.
⁵⁰ Chronic Disease Innovation Centre, Seven Oaks Hospital, Winnipeg, MB, Canada.
⁵¹ Division of Medicine, Scarborough Health Network, ON, Canada.
⁵² Can-SOLVE CKD Network, Vancouver, BC, Canada.
⁵³ William Osler Health System, Etobicoke, ON, Canada.
⁵⁴ Division of Nephrology, St. Michael's Hospital, University of Toronto, ON, Canada.
⁵⁵ Manitoba Renal Program, St. Boniface, MB, Canada.
⁵⁶ Fraser East Nephrology Associates, Abbotsford, BC, Canada.
⁵⁷ Division of Internal Medicine, Health Sciences Centre, Winnipeg, MB, Canada.
⁵⁸ Department of Internal Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada.
⁵⁹ Victoria Hospital, London Health Sciences Centre, ON, Canada.

PMID: 41393273
PMCID: PMC12696322
DOI: 10.1177/20543581251385011

Abstract
in English, French

Background: In individuals receiving hemodialysis, lower serum magnesium concentrations are associated with a higher risk of death and cardiovascular disease and more discomfort from muscle cramps. Small trials suggest that increasing serum magnesium by using a higher concentration of dialysate magnesium may be beneficial. This protocol outlines a large, randomized trial examining the effects of adopting a high versus low concentration of dialysate magnesium as a hemodialysis center-wide policy on the risk of mortality, major adverse cardiovascular events, and the burden of muscle cramps.

Objective: To determine whether implementing a dialysate magnesium concentration of 0.75 mmol/L versus ≤ 0.5 mmol/L as a hemodialysis center-wide policy, for up to 4 years, affects (1) the rate of all-cause mortality or major cardiovascular-related hospitalizations or (2) the level of discomfort individuals experience from muscle cramps.

Design: Pragmatic, 2-arm, parallel-group, registry-based, open-label, 2-sided superiority cluster randomized trial. Hemodialysis centers were randomly allocated (1:1) to one of the 2 arms. The assignment was constrained by five center-level prognostic factors and stratified by province.

Setting: 137 hemodialysis centers in four Canadian provinces-Ontario, British Columbia, Alberta, and Manitoba. The trial period is from April 4, 2022, to March 31, 2026. Outcomes will be analyzed after March 31, 2026, using provincial health care databases and self-reported questionnaires.

Participants: Individuals who received maintenance hemodialysis at participating centers during the trial period.

Intervention: Use of a dialysate magnesium concentration of either 0.75 mmol/L or ≤ 0.5 mmol/L as a center-wide policy during the trial period.

Measurements: The two primary outcomes are (1) a composite of all-cause mortality or major cardiovascular-related hospitalization (a hospital admission with myocardial infarction, congestive heart failure, or ischemic stroke) recorded in large health care databases and (2) self-reported muscle cramps collected from questionnaires.

Methods: Using an intent-to-treat approach, the intervention effect on the instantaneous rate of the primary composite outcome will be analyzed using a stratified Cox proportional hazards model accounting for center-level clustering. The observation time will be censored for provincial emigration or the trial end date. Self-reported muscle cramps will be analyzed using a cumulative link (proportional odds) model. All models will be stratified by province and adjusted for the covariates used to constrain randomization.

Limitations: The trial start date was delayed in some centers due to post-pandemic supply disruptions (including discontinued dialysate formulations); however, all centers secured dialysate concentrates in alignment with the trial-allocated magnesium level.

Conclusions: The results of this pragmatic trial will inform center-wide policy on the optimal dialysate magnesium concentration for patient health.

Trial registration: www.clinicaltrials.gov; identifier: NCT04079582.

Contexte: Chez les personnes hémodialysées, de faibles concentrations sériques de magnésium sont associées à un risque plus élevé de décès et de maladie cardiovasculaire, ainsi qu’à une intensification de l’inconfort causé par les crampes musculaires. Des essais à faible échelle suggèrent que l’utilisation d’un dialysat plus riche en magnésium pourrait augmenter le taux de magnésium sérique, avec des effets potentiellement bénéfiques. Ce protocole décrit un vaste essai randomisé examinant les effets de l’adoption, comme politique institutionnelle, d’un dialysat à concentration élevée ou faible en magnésium sur la mortalité, les événements cardiovasculaires majeurs et la fréquence des crampes musculaires.

Objectif: Déterminer si l’adoption, sur une période pouvant aller jusqu’à 4 ans, d’une politique institutionnelle recommandant d’utiliser un dialysat à 0,75 mmol/l ou à ≤ 0,5 mmol/l de magnésium, affecte (i) le taux de mortalité toutes causes confondues ou d’hospitalisations majeures liées à un événement cardiovasculaire ou (ii) le niveau d’inconfort ressenti par les personnes en raison de crampes musculaires.

Conception: Essai randomisé en grappes, pragmatique, à deux bras parallèles, ouvert et basé sur un registre, visant à démontrer une supériorité bilatérale. Les centres d’hémodialyse ont été répartis aléatoirement (1:1) dans l’un des deux bras. La répartition a pris en compte cinq facteurs pronostiques propres aux centres et a été stratifiée selon la province.

Cadre: 137 centres d’hémodialyse dans quatre provinces canadiennes : Ontario, Colombie-Britannique, Alberta et Manitoba. L’essai est réalisé du 4 avril 2022 au 31 mars 2026. L’analyse des résultats sera effectuée après le 31 mars 2026, en s’appuyant sur les bases de données de santé provinciales et les questionnaires autodéclarés.

Sujets: Des personnes recevant une hémodialyse d’entretien dans les centres participants pendant la période de l’essai.

Intervention: Une politique institutionnelle recommandant une concentration en magnésium de 0,75 mmol/l ou de ≤ 0,5 mmol/l dans le dialysat pendant la période d’essai.

Mesures: Les deux principaux critères de jugement sont : (i) un composite de mortalité toutes causes confondues ou d’hospitalisation majeure liée à un événement cardiovasculaire (infarctus du myocarde, insuffisance cardiaque congestive ou AVC ischémique) enregistré dans les grandes bases de données de santé et (ii) des crampes musculaires autodéclarées dans les questionnaires.

Méthodologie: L’effet de l’intervention sur le taux de survenue du critère principal sera évalué en intention de traiter, au moyen d’un modèle des risques proportionnels de Cox stratifié, en prenant en compte la corrélation des données au sein des centres. Le suivi des participants prendra fin s’ils quittent la province, sinon à la fin de l’essai. Les crampes musculaires autodéclarées seront analysées à l’aide d’un modèle à liaison cumulative (modèle des rapports proportionnels). L’ensemble des modèles sera stratifié par province et ajusté selon les covariables ayant servi à restreindre la randomisation.

Limites: Le début de l’essai a été retardé dans certains centres en raison de perturbations de l’approvisionnement postpandémie (notamment l’indisponibilité de certaines formulations de dialysat). Tous les centres ont cependant pu obtenir des concentrés de dialysat conformes au taux de magnésium attribué pour l’essai.

Conclusion: Les résultats de cet essai pragmatique aideront les centres à définir une politique institutionnelle sur la concentration optimale de magnésium dans le dialysat pour favoriser la santé des patients.

Keywords: cardiovascular events; cluster randomized trial; dialysate; dialysis; magnesium; mortality; muscle cramps.

PubMed Disclaimer

Conflict of interest statement

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. The Ontario dataset of this study (excluding muscle cramp data) will be held securely in coded form at ICES (formerly the Institute for Clinical Evaluative Sciences). While legal data-sharing agreements between ICES and data providers (eg, health care organizations and government) prohibit ICES from making the data publicly available, access may be granted to those who meet prespecified criteria for confidential access, available at www.ices.on.ca/DAS (email: das@ices.on.ca). The full dataset creation plan and underlying analytic code are available from the authors upon request, understanding that the computer programs may rely upon coding templates or macros that are unique to ICES and therefore inaccessible or may require modification. Access to data provided by Population Data British Columbia is subject to approval but can be requested for research projects through the Data Steward(s) or their designated service providers. The Alberta dataset (excluding muscle cramp data) will be held securely in coded form within Alberta Health Services and Alberta Health. Legal data-sharing agreements between Alberta Strategy for Patient Oriented Research Support Unit (AbSPORU) and the data providers (Alberta Health Services, Alberta Health) prohibit AbSPORU from making the data set publicly available. The source data used in the Manitoba dataset (excluding muscle cramp data) were originally collected during the routine administration of health services in Manitoba. They were provided to the Manitoba Centre for Health Policy (MCHP) for secondary use in research under specific data-sharing agreements between the data trustees and MCHP. The data are approved for use at MCHP only. They are not owned by the researchers or by MCHP and cannot be deposited in a public repository. To review source data specific to this article or project, interested parties should contact the MCHP Repository Access & Use team at MCHP.Access@umanitoba.ca. The team will then facilitate data access by seeking the consent of the original data holders and the required privacy and ethics review bodies. Research studies using First Nations data require ethics approval from the Health Information Research Governance Committee at the First Nations Health and Social Secretariat of Manitoba (https://www.fnhssm.com/hirgc), and we comply with their policies for data access, linkage, and sharing. For inquiries about accessing Manitoba First Nations data, please contact info@fnhssm.com. Muscle cramp data collection for this trial will be held securely at Pragmatic Trials Services in London, Ontario. Sharing of this data outside the research team is not permissible due to existing data sharing agreements.

Figures

**Figure 1.**
PRECIS-2 wheel highlighting the pragmatism of the Dial-Mag trial for 9 domains. PRECISPRagmatic Explanatory Continuum Indicator Summary.

**Figure 2.**
Map depicting the location of the 137 hemodialysis centers participating in the Dial-Mag trial. *Note.* 82 centers were in Ontario, and 19, 25, and 11 centers in British Columbia, Alberta, and Manitoba, respectively.

**Figure 3.**
Application of trial eligibility criteria to centers offering facility-based maintenance hemodialysis in Ontario, British Columbia, Alberta, and Manitoba (as of December 3, 2021).

**Figure 4.**
Example of the flyer distributed to all individuals receiving hemodialysis in all participating centers at the start of the Dial-Mag trial and then approximately every 6 months. *Note.* The flyers were available in 19 different languages.

See this image and copyright information in PMC

References

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1. Jassal SV, Trpeski L, Zhu N, Fenton S, Hemmelgarn B. Changes in survival among elderly patients initiating dialysis from 1990 to 1999. Can Med Assoc J. 2007;177(9):1033-1038. doi: 10.1503/cmaj.061765. - DOI - PMC - PubMed
1. Foote C, Ninomiya T, Gallagher M, et al. Survival of elderly dialysis patients is predicted by both patient and practice characteristics. Nephrol Dial Transplant. 2012;27(9):3581-3587. doi: 10.1093/ndt/gfs096. - DOI - PubMed
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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

Affiliations

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

Authors

Affiliations

Abstract
in English, French

Conflict of interest statement

Figures

References

Associated data

LinkOut - more resources

Full Text Sources

Medical

Research Materials

Miscellaneous

Abstract in English, French

Conflict of interest statement

Figures

References

Associated data

LinkOut - more resources

Full Text Sources

Medical

Research Materials

Miscellaneous

Abstract
in English, French