Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients

Phase 4

Recruiting

• Conditions: Critical Illness; New Onset Atrial Fibrillation
• Interventions: Drug: Placebo; Drug: Magnesium sulfate

• Registration Number: NCT05829317
• Lead Sponsor: Dr. Stephanie Sibley

Brief Summary

A double-blind, multi-centre, randomized, placebo-controlled, feasibility pilot trial in the prevention of new onset atrial fibrillation of critically ill patients admitted to an ICU.

Detailed Description

Most studies of new onset atrial fibrillation (NOAF) in critical illness focus on treatment of this arrhythmia but this innovative study will focus on prevention. Parenteral Mg is a low cost and readily available treatment that may be beneficial for reducing the incidence of NOAF in critically ill patients, with the potential to improve patient centred outcomes and provide a cost effective prophylaxis. The main outcome of this study is to determine if it is feasible to conduct a randomized controlled trial comparing parenteral magnesium sulfate with placebo for the prophylaxis of new onset atrial fibrillation in critically ill patients.

Study Timeline

• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-25
• Study Start: 2023-08-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2025-03
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Age ≥18 years

2. Admitted to a critical care unit with EITHER:

   1. Non-invasive ventilation (including high flow nasal canula) or invasive mechanical ventilation with an expected duration >24 hours AND/OR
   2. Vasopressor or ionotropic support for shock of any etiology. Shock is defined by the need for one of the following vasopressors/inotropes:

   Dopamine Dobutamine Norepinephrine Epinephrine Ephedirine Milrinone at any dose (if used in conjunction with another agent) Vasopressin (if used in conjunction with another agent)

3. Receiving continuous cardiac monitoring.

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Exclusion Criteria

1. Active atrial fibrillation prior to randomization or pre-existing (permanent or paroxysmal) atrial fibrillation
2. Unlikely to survive >24 hours or palliative patients
3. Cardiac surgery patients
4. Patients requiring parenteral magnesium therapy (e.g. pre-eclampsia, asthma)
5. Patients receiving dialysis
6. Positive pregnancy test
7. Previously enrolled in this trial
8. Treating physician refuses enrollment
9. Receiving ICU intervention (Non-invasive ventilation including High flow nasal canula, invasive mechanical ventilation or ionotropic support) for >18h hours

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% NaCl	Placebo	100mL 0.9% NaCl BID, given intravenously over 2 hours, for a total of 10 doses
Magnesium Sulfate	Magnesium sulfate	4g Magnesium sulfate (100mL) BID, given intravenously over 2 hours, for a total of 10 doses

Primary Outcome Measures

Name	Time	Method
RCT Feasibility	90 days	3) CardioSTAT tolerance and use ≥ 90% (defined appropriate placement, uninterrupted wear, and returned monitors)

Secondary Outcome Measures

Name	Time	Method
Acute Care Outcomes	28 days	mortality
Hospital Outcomes	28 days	hospital length of stay

Trial Locations

Locations (1)

Kingston Health Sciences Centre; 🇨🇦 Kingston, Ontario, Canada