Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnesium sulfate, Placebo.
- Who it may be relevant to
- Registry conditions: Critical Illness, New Onset Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Parenteral Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients - a Pilot Feasibility Study
Overview
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
- Drug Magnesium sulfate
Intravenous Magnesium sulfate - Drug Placebo
0.9% NaCl
Primary outcome measures
- RCT Feasibility [Time frame: 90 days]
- RCT Feasibility [Time frame: 90 days]
Secondary outcome measures (5)
- Equipoise and Feasibility [Time frame: 365 days]
- Acute Care Outcomes [Time frame: 28 days]
- Hospital Outcomes [Time frame: 28 days]
- Adverse Events [Time frame: 28 days]
- Functional Outcomes [Time frame: 365 days]
Eligibility criteria
Inclusion criteria
- Age ≥18 years;
- Admitted to an ICU with one or more of the following:
- 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)
- Vasopressor or inotropic support with an expected duration of >24 hours
- Cardiac arrest
- Continuous cardiac monitoring.
Exclusion criteria
- Receiving ICU intervention (Non-invasive ventilation (including high flow nasal canula), invasive mechanical ventilation or inotropic support) for >18 hours
- Receiving IMV for airway protection only (for example, isolated head trauma)
- Active atrial fibrillation at the time of enrolment
- On oral or continuous infusion of Amiodarone
- Unlikely to survive >24 hours or palliative patients
- Cardiac surgery patients
- Patients requiring parenteral magnesium therapy (e.g. pre-eclampsia, asthma)
- Patients receiving dialysis
- Positive pregnancy test (females <50 years old)
- Previously enrolled in this trial
- Treating physician refuses enrollment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Canada · 4 centers
- St Joseph's Healthcare Hamilton — Hamilton
- Kingston Health Sciences Centre — Kingston
- The Ottawa Hospital - General Campus — Ottawa
- The Ottawa Hospital - Civic Campus — Ottawa
Identifiers
NCT: NCT05829317 · ATOMIC