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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
Intravenous Magnesium sulfate
0.9% NaCl
St Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
NOT_YET_RECRUITINGKingston Health Sciences Centre
Kingston, Ontario, Canada
RECRUITINGThe Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
NOT_YET_RECRUITINGRCT Feasibility
To assess feasibility of patient recruitment, randomization procedures, intervention and data collection and measure protocol adherence. Protocol adherence ≥ 90% (We define protocol adherence as administration of first dose of study drug within 18 hours (+1hr window) of 1st ICU intervention (life sustaining therapy) delivery of all additional
Time frame: 90 days
RCT Feasibility
Recruitment rate of ≥ 2 patients/month/ICU
Time frame: 90 days
Equipoise and Feasibility
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.
Time frame: 365 days
Acute Care Outcomes
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
Time frame: 28 days
Hospital Outcomes
Days alive and ventilator free, ICU length of stay, and hospital length of stay.
Time frame: 28 days
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The Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada
NOT_YET_RECRUITINGAdverse Events
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.
Time frame: 28 days
Functional Outcomes
EQ-5D score, death after discharge.
Time frame: 365 days