Effect of Protocolized Magnesium Replacement on Mortality and Atrial Fibrillation in Critically Ill Patients

NCT07173855 | Recruiting Phase 4

• 1 other identifier: ICU-25-018
• Study Type: interventional
• Target: 3,253
• Locations: 1 country
• Sites: 6

Brief Summary

In patients with critical illness, such as severe infections, heart attacks, or respiratory failure, most intensive care units (ICUs) measure magnesium levels and give supplemental doses of magnesium when levels are below certain targets. However, the best targets are unknown. The goal of this clinical trial is to study protocols for magnesium supplementation in people with critical illness, comparing a protocol with higher target level to a protocol with a lower target level. 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.

Conditions

Critical Illness

Keywords

Critical illness; Magnesium; Atrial fibrillation; Protocols

Outcome Measures

Primary Outcomes (1)

• 30-day ordinal composite of hospital mortality and days free of atrial fibrillation in ICU

  This is an ordinal outcome with 32 levels ranging from -1 (worst) to 30 (best). It is evaluated at 30 days. The worst outcome (-1) corresponds to mortality in hospital within 30 days from trial enrollment. Among patients who do not die in hospital by day 30, we count the number of days when they did not have atrial fibrillation in the ICU. For example, a survivor who never had atrial fibrillation in ICU would be scored as "30." A survivor who had 5 days of atrial fibrillation in ICU would be scored as "25." A patient who is discharged from hospital, either to home or transferred to another site, but is readmitted to a study hospital and dies within 30 days of enrollment, would be counted as having had hospital mortality. This stipulation is relevant because of the frequency of transfers between sites within a health network, due to regionalization of services such as vascular surgery, thoracic surgery, dialysis, and angiography.

  30 days after enrollment.

Secondary Outcomes (18)

• Organ-support free days

  30 days

• ICU-free days

  30 days

• Invasive ventilation-free days

  30 days

• Vasopressor-free days

  30 days

• Renal replacement therapy-free days

  30 days

Study Arms (2)

Lower target (>0.7mmol)

OTHER

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.

Drug: Magnesium sulfate administration

Higher target (>0.95mmol/L)

OTHER

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.

Drug: Magnesium sulfate administration; Drug: Magnesium oxide; Drug: Magnesium glucoheptonate

Interventions

Magnesium sulfate administration DRUG

Magnesium sulfate is used in both arms for magnesium replacement.

Higher target (>0.95mmol/L); Lower target (>0.7mmol)

Magnesium oxide DRUG

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.

Higher target (>0.95mmol/L)

Magnesium glucoheptonate DRUG

Magnesium glucoheptonate 30mL po q12h x 2 is an oral option for magnesium replacement in the higher-target arm.

Higher target (>0.95mmol/L)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 16 years or older
• Admission orders written to a medical-surgical intensive care unit at a participating site
• Magnesium replacement protocol ordered

You may not qualify if:

• Prior enrollment in or withdrawal from MAGNOLIA trial
• Sustained ventricular tachycardia
• Pre-eclampsia
• Myasthenia gravis

Sponsors & Collaborators

• Scarborough General Hospital: lead
• Scarborough Health Network: collaborator
• Lakeridge Health Corporation: collaborator

Study Sites (6)

Lakeridge Health Ajax-Pickering

Ajax, Ontario, L1S 2J4, Canada

RECRUITING

Lakeridge Health Bowmanville

Bowmanville, Ontario, L1C 2N3, Canada

RECRUITING

Lakeridge Health Oshawa

Oshawa, Ontario, L1G 8A2, Canada

RECRUITING

Scarborough Centenary Hospital

Toronto, Ontario, M1E 4B9, Canada

RECRUITING

Scarborough General Hospital

Toronto, Ontario, M1P2V5, Canada

RECRUITING

Scarborough Birchmount Hospital

Toronto, Ontario, M1W 3W3, Canada

RECRUITING

MeSH Terms

Conditions

Critical Illness; Atrial Fibrillation

Interventions

Magnesium Oxide; alpha-glucoheptonic acid

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds

Central Study Contacts

Joshua Craig

CONTACT

4164382911; jcraig@shn.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intensivist and Researcher

Model Details: Pragmatic comparative effectiveness trial

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Deidentified data will be posted in the Health Data Nexus repository after publication of the primary trial results.
• Access Criteria: Credentialed access to the Health Data Nexus is available to anyone who fulfills the requirements, including an ethics course (TCPS2 2022) and signing a data use agreement.

Locations

CA (6)