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

Dr. Stephanie Sibley

Status and phase: Enrolling; Phase 4

Conditions: New Onset Atrial Fibrillation; Critical Illness

Treatments: Drug: Placebo; Drug: Magnesium sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT05829317

ATOMIC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years

2. Admitted to a critical care unit with EITHER:

   1. Non-invasive ventilation (including high flow nasal canula) or invasive mechanical ventilation with an expected duration >24 hours AND/OR
   2. Vasopressor or ionotropic support for shock of any etiology. Shock is defined by the need for one of the following vasopressors/inotropes:

   Dopamine Dobutamine Norepinephrine Epinephrine Ephedirine Milrinone at any dose (if used in conjunction with another agent) Vasopressin (if used in conjunction with another agent)

3. Receiving continuous cardiac monitoring.

Exclusion criteria

1. Active atrial fibrillation prior to randomization or pre-existing (permanent or paroxysmal) atrial fibrillation
2. Unlikely to survive >24 hours or palliative patients
3. Cardiac surgery patients
4. Patients requiring parenteral magnesium therapy (e.g. pre-eclampsia, asthma)
5. Patients receiving dialysis
6. Positive pregnancy test
7. Previously enrolled in this trial
8. Treating physician refuses enrollment
9. Receiving ICU intervention (Non-invasive ventilation including High flow nasal canula, invasive mechanical ventilation or ionotropic support) for >18h hours

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Magnesium Sulfate

Experimental group

Description:

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

Treatment:

Drug: Magnesium sulfate

0.9% NaCl

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo