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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Critical Illness, New Onset Atrial Fibrillation

Intervention / Treatment
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* Drug: Magnesium sulfate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Admitted to a critical care unit with EITHER: Non-invasive ventilation (including high flow nasal canula) or invasive mechanical ventilation with an expected duration >24 hours AND/OR 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) Receiving continuous cardiac monitoring. Exclusion Criteria: >12 hours from ICU admission Active atrial fibrillation prior to randomization or pre-existing (permanent or paroxysmal) atrial fibrillation Unlikely to survive >24 hours or palliative patients Cardiac surgery patients Patients requiring parenteral magnesium therapy (e.g. pre-eclampsia, asthma) Transfer from another ICU Patients receiving dialysis Positive pregnancy test Previously enrolled in this trial Treating physician refuses enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium Sulfate<br>4g Magnesium sulfate (100mL) BID, given intravenously over 2 hours, for a total of 10 doses | Drug: Magnesium sulfate<br>* Intravenous Magnesium sulfate<br>|
| Placebo Comparator: 0.9% NaCl<br>100mL 0.9% NaCl BID, given intravenously over 2 hours, for a total of 10 doses | Drug: Placebo<br>* 0.9% NaCl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RCT Feasibility | 1) Protocol adherence ≥ 90% (We define protocol adherence as administration of first dose of study drug within 12 hours starting supported ventilation or vasoactive medications, delivery of all additional doses of study drugs for the following 4 days in patients who do not meet any stopping criteria, including patients transferred to the ward) | 90 days | 
| RCT Feasibility | 2) Recruitment rate of ≥ 6 patients/month (2 patient/month/ICU) | 90 days | 
| RCT Feasibility | 3) CardioSTAT tolerance and use ≥ 90% (defined appropriate placement, uninterrupted wear, and returned monitors) | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Care Outcomes | Total number of patients developing NOAF within 14 days of enrolment | 28 days | 
| Acute Care Outcomes | Use of rate and rhythm controlling agents, vasoactive agents, diuretics, steroids, anticoagulants | 28 days | 
| Acute Care Outcomes | bleeding events | 28 days | 
| Acute Care Outcomes | thromboembolic events | 28 days | 
| Acute Care Outcomes | persistent organ disfunction | 28 days | 
| Acute Care Outcomes | mortality | 28 days | 
| Hospital Outcomes | Development of renal failure requiring dialysis | 28 days | 
| Hospital Outcomes | ICU length of stay | 28 days | 
| Hospital Outcomes | hospital length of stay | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prophylaxis, Prevention