Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients
- Conditions
- Critical IllnessNew Onset Atrial Fibrillation
- Interventions
- Drug: Placebo
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
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 Recruitment rate of ≥ 2 patients/month/ICU
- Secondary Outcome Measures
Name Time Method Equipoise and Feasibility 365 days Physician willingness to recruit patients in the setting of existing electrolyte replacement protocols; effectiveness of blinding; proportion of patients who meet eligibility criteria of those admitted to ICU; proportion of eligible patients for whom consent is obtained; proportion of patients who re-consent when they regain capacity for those randomized under the deferred consent model; proportion of patients lost to follow-up; time for research personnel to complete study related tasks.
Acute Care Outcomes 28 days Total number of patients developing AF within 28 days of enrolment (AF will be defined as at least 30 seconds of NOAF detected by cardiac monitoring or ECG); Use of rate and rhythm controlling agents, vasoactive agents, diuretics, steroids, anticoagulants, bleeding events, thromboembolic events (as defined in the 2018 Canadian Stroke Best Practices Guideline1; these will be adjudicated by a neurologist blinded to study groups), persistent organ dysfunction, mortality
Hospital Outcomes 28 days Days alive and ventilator free, ICU length of stay, and hospital length of stay.
Adverse Events 28 days Adverse drug reactions including bradycardia (HR \<60 bpm); severe bradycardia (HR \<50 bpm); clinically significant bradycardia (bradycardia requiring inotropes, vasopressors, external pacing, temporary pacemaker, or discontinuation of the trial medication); hypotension (MAP\< 65mmHg, or systolic blood pressure \[SBP\]\>20mmHg below admission baseline); clinically significant hypotension (hypotension requiring vasopressors, fluid administration, or discontinuation of the trial medication) while the study drug is being infused.
Functional Outcomes 365 days EQ-5D score, death after discharge.
Trial Locations
- Locations (4)
St Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada
The Ottawa Hospital - General Campus
🇨🇦Ottawa, Ontario, Canada
The Ottawa Hospital - Civic Campus
🇨🇦Ottawa, Ontario, Canada
Kingston Health Sciences Centre
🇨🇦Kingston, Ontario, Canada
St Joseph's Healthcare Hamilton🇨🇦Hamilton, Ontario, CanadaDr. Deborah Cook, MDContact