Effect of Protocolized Magnesium Replacement on Mortality and Atrial Fibrillation in Critically Ill Patients
NCT ID: NCT07173855
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
3253 participants
INTERVENTIONAL
2025-11-25
2027-06-01
Brief Summary
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The main question this study aims to answer is whether magnesium supplementation protocols targeting a higher or lower level lead to better 30-day survival and less atrial fibrillation.
Participants will not have to do any specific tasks, undergo any additional tests, or complete any surveys.
Detailed Description
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Methods: Multi-center open-label parallel group randomized controlled superiority trial of adult critically ill patients receiving protocolized magnesium replacement, comparing a higher target (\>0.95mmol/L) to a lower target (\>0.7mmol/L). The trial will be embedded into the electronic medical record (EMR) at 5 hospitals across 2 health networks in Ontario, Canada, with a shared EMR. Patients aged 16 years or older who have ICU admission orders and an order for the magnesium replacement protocol will be included. Patients with pre-eclampsia, sustained ventricular tachycardia, or neuromuscular junction disease will be excluded. The primary outcome will be an ordinal composite, evaluated at 30 days, composed of death and the number of days free of atrial fibrillation or flutter in ICU. Secondary outcomes will include ventricular arrhythmia and antiarrhythmics administered; receipt of vasopressors, ventilation, and new renal replacement therapy in ICU; lengths of ICU and hospital stay; hospital mortality at 60 and 90 days, magnesium levels, and magnesium supplementation. Analyses will use Bayesian regression with weakly skeptical priors and an intention-to-treat approach. Because both targets lie within the standard of care, the trial will use opt-out consent. Screening will be integrated with the EMR, such that when a patient meets inclusion criteria, a pop-up will appear for the ordering clinician. After the clinician confirms eligibility, the patient will be randomized and assigned to their target. Outcome ascertainment will occur within the EMR.
Discussion: This randomized controlled trial addresses an important uncertainty regarding routine care in the ICU with an EMR-embedded design. The innovative EMR-embedded design facilitates the large sample sizes and comprehensive, equitable recruitment needed for a trial evaluating a routine care intervention, and will lead to seamless integration with routine care upon trial completion.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lower target (>0.7mmol)
Protocolized magnesium replacement according to magnesium level as follows: for 0.45 - 0.70mmol/L, magnesium sulfate 4g IV x 1 and repeat magnesium level the next day; for \< 0.45mmol/L, magnesium sulfate 6g IV x 1, alert most responsible physician, and repeat level in 4 hours.
Magnesium sulfate administration
Magnesium sulfate is used in both arms for magnesium replacement.
Higher target (>0.95mmol/L)
Protocolized magnesium replacement according to magnesium level as follows: for 0.75-0.95mmol/L, magnesium sulfate 2g IV x 1, magnesium oxide 420 mg po q12h x 2, or magnesium glucoheptonate 30mL po q12h x 2; for 0.45 - 0.74mmol/L, magnesium sulfate 4g IV x 1 and repeat magnesium level the next day; for \< 0.45mmol/L, magnesium sulfate 6g IV x 1, alert most responsible physician, and repeat level in 4 hours.
Magnesium sulfate administration
Magnesium sulfate is used in both arms for magnesium replacement.
Magnesium oxide
In the higher-target arm, magnesium oxide 420mg po q12h x 2 is one of the options available for magnesium replacement when magnesium levels lie between 0.75 and 0.95mmol/L.
Magnesium glucoheptonate
Magnesium glucoheptonate 30mL po q12h x 2 is an oral option for magnesium replacement in the higher-target arm.
Interventions
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Magnesium sulfate administration
Magnesium sulfate is used in both arms for magnesium replacement.
Magnesium oxide
In the higher-target arm, magnesium oxide 420mg po q12h x 2 is one of the options available for magnesium replacement when magnesium levels lie between 0.75 and 0.95mmol/L.
Magnesium glucoheptonate
Magnesium glucoheptonate 30mL po q12h x 2 is an oral option for magnesium replacement in the higher-target arm.
Eligibility Criteria
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Inclusion Criteria
* Admission orders written to a medical-surgical intensive care unit at a participating site
* Magnesium replacement protocol ordered
Exclusion Criteria
* Sustained ventricular tachycardia
* Pre-eclampsia
* Myasthenia gravis
16 Years
ALL
No
Sponsors
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Scarborough Health Network
UNKNOWN
Lakeridge Health Corporation
OTHER
Scarborough General Hospital
OTHER
Responsible Party
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Christopher Yarnell
Intensivist and Researcher
Locations
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Lakeridge Health Ajax-Pickering
Ajax, Ontario, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Scarborough Centenary Hospital
Toronto, Ontario, Canada
Scarborough General Hospital
Toronto, Ontario, Canada
Scarborough Birchmount Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Joshua Craig
Role: primary
Joshua Craig
Role: primary
Joshua Craig
Role: primary
Other Identifiers
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ICU-25-018
Identifier Type: -
Identifier Source: org_study_id