Parenteral Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients - a Pilot Feasibility Study

ATOMIC

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.

2023-08-20

2025-03-01

2025-07-01

Recruiting

Early phase I

140

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. \>12 hours from ICU admission 2. Active atrial fibrillation prior to randomization or pre-existing (permanent or paroxysmal) atrial fibrillation 3. Unlikely to survive \>24 hours or palliative patients 4. Cardiac surgery patients 5. Patients requiring parenteral magnesium therapy (e.g. pre-eclampsia, asthma) 6. Transfer from another ICU 7. Patients receiving dialysis 8. Positive pregnancy test 9. Previously enrolled in this trial 10. Treating physician refuses enrollment

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}

2023-11-18