POMPAE trial. Peri-Operative Magnesium infusion to Prevent Atrial fibrillation Evaluated.
- Conditions
- Atrial fibrillation
- Registration Number
- NL-OMON24637
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 812
Elective cardiac surgery (valve surgery and/or CABG)
-18 years and above
-History of atrial fibrillation (AF) and atrial flutter
-Concomitant procedures (MAZE (surgical ablation)/PVI (pulmonary vein isolation))
-Pre-existing severe renal impairment (eGFR<30 ml/min) or development of oliguria post-surgery (<200 ml in previous 6 hours) and/or rise in creatinine with eGFR <30 ml/min)
-Significant hypotension persisting for 1 hour or longer (Noradrenaline >0.1 mcg/kg/min)
- Third-degree heart block without pacemaker in situ
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ewly diagnosed AF over a period of 5 minutes or longer
- Secondary Outcome Measures
Name Time Method 1.28-day AF post-surgery. <br>2.Length of Hospital Stay (LOHS) and ICU LOS<br>3.Duration of mechanical ventilation<br>4.Duration of inotropic or vasopressor support<br>5.Combined outcome including 28-day post-surgery mortality, stroke, pulmonary embolism, delirium (requiring any form and/or duration of anti-psychotic medication) and infection requiring antibiotics.