Using magnesium to prevent new atrial fibrillation in critically ill patients

Parenteral Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients - a Pilot Feasibility Study

This study is testing if giving magnesium to critically ill patients in the ICU can help prevent new cases of atrial fibrillation.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Queen's University (Academic / other)
• Locations: 4 sites (Hamilton, Ontario and 3 other locations)
• Trial ID: NCT05829317 on ClinicalTrials.gov

What this trial studies

This is a double-blind, multi-centre, randomized, placebo-controlled feasibility pilot trial aimed at preventing new onset atrial fibrillation (NOAF) in critically ill patients admitted to an ICU. The study will compare the effects of parenteral magnesium sulfate against a placebo to assess its feasibility in reducing the incidence of NOAF. By focusing on prevention rather than treatment, this innovative approach seeks to improve patient outcomes and provide a cost-effective prophylactic option. The primary goal is to determine the feasibility of conducting a larger randomized controlled trial based on the initial findings.

Who should consider this trial

Good fit: Ideal candidates include critically ill patients aged 18 and older who require non-invasive or invasive mechanical ventilation or vasopressor support.

Not a fit: Patients with active or pre-existing atrial fibrillation, those unlikely to survive beyond 24 hours, or those requiring parenteral magnesium therapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence of new onset atrial fibrillation in critically ill patients, leading to better overall outcomes.

How similar studies have performed: While many studies focus on treating atrial fibrillation, this preventive approach using magnesium is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria

1. Age ≥18 years;
2. Admitted to an ICU with one or more of the following:

   1. Non-invasive ventilation (including CPAP, Bipap and high flow oxygen (\>10L/min) or invasive mechanical ventilation with an expected duration \>24 hours for respiratory failure (hypercarbic or hypoxic)
   2. Vasopressor or inotropic support with an expected duration of \>24 hours
   3. Cardiac arrest
3. Continuous cardiac monitoring.

Exclusion Criteria

1. Receiving ICU intervention (Non-invasive ventilation (including high flow nasal canula), invasive mechanical ventilation or inotropic support) for \>18 hours
2. Receiving IMV for airway protection only (for example, isolated head trauma)
3. Active atrial fibrillation at the time of enrolment
4. On oral or continuous infusion of Amiodarone
5. Unlikely to survive \>24 hours or palliative patients
6. Cardiac surgery patients
7. Patients requiring parenteral magnesium therapy (e.g. pre-eclampsia, asthma)
8. Patients receiving dialysis
9. Positive pregnancy test (females \<50 years old)
10. Previously enrolled in this trial
11. Treating physician refuses enrollment

Where this trial is running

Hamilton, Ontario and 3 other locations

• St Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (Not_yet_recruiting)
• Kingston Health Sciences Centre — Kingston, Ontario, Canada (Recruiting)
• The Ottawa Hospital - General Campus — Ottawa, Ontario, Canada (Not_yet_recruiting)
• The Ottawa Hospital - Civic Campus — Ottawa, Ontario, Canada (Not_yet_recruiting)

Study contacts

• Principal investigator: Stephanie Sibley, MD — Queen's University
• Study coordinator: Miranda Hunt

Conditions Critical Illness; New Onset Atrial Fibrillation; Prophylaxis; Prevention