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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04079582
Recruitment Status : Not yet recruiting
First Posted : September 6, 2019
Last Update Posted : April 26, 2021
Sponsor:
Collaborators:
ICES
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Lawson Health Research Institute

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 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 all patients on dialysis.


Condition or disease Intervention/treatment Phase
Kidney Diseases End-Stage Kidney Disease Hemodialysis Other: Dialysate magnesium formulation of 1.5 mEq/L (0.75 mmol/L). Other: Dialysate magnesium formulation of ≤1.0 mEq/L (≤0.5 mmol/L). Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Outcomes of a Higher vs. Lower Hemodialysate Magnesium Concentration: A Pragmatic Cluster-randomized Clinical Trial in Hemodialysis Centres
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Magnesium

Arm Intervention/treatment
Experimental: Higher dialysate magnesium Other: Dialysate magnesium formulation of 1.5 mEq/L (0.75 mmol/L).
(Dialysate magnesium concentration currently used in Canada and the United States)

Active Comparator: Lower dialysate magnesium Other: Dialysate magnesium formulation of ≤1.0 mEq/L (≤0.5 mmol/L).
(Dialysate magnesium concentration currently used in Canada and the United States)




Primary Outcome Measures :
  1. Composite outcome of cardiovascular-related hospitalization and all-cause mortality [ Time Frame: Three to Four Years ]
    Cardiovascular-related hospitalization (for myocardial infarction, ischemic stroke, or congestive heart failure) will be ascertained using primary discharge ICD-10 diagnosis codes in the Canadian Institute for Health Information's Discharge Abstract Database. All-cause mortality is recorded with over 99% accuracy in our data sources.


Secondary Outcome Measures :
  1. Key secondary outcome - patient-reported muscle cramps [ Time Frame: Three to Four Years ]
    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 10-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.

  2. Components of the primary composite outcome [ Time Frame: Three to Four Years ]
    Each component of the primary composite outcome (all-cause mortality and hospitalizations for myocardial infarction, ischemic stroke, and congestive heart failure) will be examined separately.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: This pragmatic cluster randomized controlled trial has only two inclusion criteria:

  1. The hemodialysis centre, or a group of hemodialysis centers combined into one cluster, must care for at least 15 outpatients being treated with in-centre maintenance hemodialysis.
  2. The medical director of the hemodialysis centre must be willing for their centre to be randomized and to adopt the allocated dialysate Mg protocol as their standard solution for the duration of the trial.

Exclusion Criteria:

  • The centre, or group of hemodialysis centres cares for less than 15 patients being treated with conventional in-centre hemodialysis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04079582


Contacts
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Contact: Amit X Garg, PhD, MD 519-685-8502 amit.garg@lhsc.on.ca

Locations
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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A5W9
Sponsors and Collaborators
Lawson Health Research Institute
ICES
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Amit X Garg, PhD, MD ICES, Lawson, London Health Sciences Centre
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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04079582    
Other Study ID Numbers: R-13-999
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lawson Health Research Institute:
Dialysate Magnesium
Kidney Disease
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Cluster Randomized Controlled Trial
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Dialysis Solutions
Pharmaceutical Solutions