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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-20

Study Completion Date

2028-07-01

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.

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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.

Conditions

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Critical Illness New Onset Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Magnesium Sulfate

4g Magnesium sulfate (100mL) BID, given intravenously over 2 hours, for a total of 10 doses

Group Type EXPERIMENTAL

Magnesium sulfate

Intervention Type DRUG

Intravenous Magnesium sulfate

0.9% NaCl

100mL 0.9% NaCl BID, given intravenously over 2 hours, for a total of 10 doses

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.9% NaCl

Interventions

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Magnesium sulfate

Intravenous Magnesium sulfate

Intervention Type DRUG

Placebo

0.9% NaCl

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No