Critical Illness, New Onset Atrial Fibrillation
Conditions
Keywords
Prophylaxis, Prevention
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.
Interventions
DRUGMagnesium sulfate
Intravenous Magnesium sulfate
DRUGPlacebo
0.9% NaCl
Sponsors
Southeastern Ontario Academic Medical Organization (SEAMO)
Canadian Institutes of Health Research (CIHR)
Dr. Stephanie Sibley
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RCT Feasibility | 90 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Contacts
Primary ContactMiranda Hunt
Outcome results
None listed