Randomized Controlled Trial of Magnesium Sulfate Versus Placebo on the Prevention of Atrial Fibrillation Post Cardiac Surgery.

T-21-118

Post-operative atrial fibrillation (POAF) is commonly observed in patients post cardiac surgery without a previous history of atrial fibrillation (AF) or other arrythmias. It's associated with significant postoperative complications including infection, bleeding reoperation, increased hospital length of stay (LOHS) and mortality. Magnesium has been identified as a potentially interesting compound with easy access and low toxicity. Hypomagnesemia has been observed frequently immediately after cardiac surgery. Both reduction of abnormal atomicity of atrial myocardium and prolongation of the atrial refractory period caused by administration of magnesium may prevent AF. The POMPAE trial will analyse the effectiveness of MgSO4 versus placebo (double blind randomized trial) in the prevention of POAF after cardiac surgery.

2022-08-01

2024-12-31

2025-01-31

Recruiting

Early phase I

530

Inclusion Criteria: * Elective cardiac surgery (valve surgery and/or CABG) * 18 years and above * Mentally competent Exclusion Criteria: * History of atrial fibrillation (AF) or atrial flutter. * Concomitant rhythm associated procedures (MAZE (surgical ablation)/PVI (pulmonary vein isolation)). * Pre-existing severe renal impairment (eGFR\<30 ml/min). * Pre-existing 3rd degree heart block without pacemaker presence.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blinded RCT', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 530, 'type': 'ESTIMATED'}}

2024-01-09