POMPAE trial. Peri-Operative Magnesium infusion to Prevent Atrial fibrillation Evaluated.

Randomized controlled trial of magnesium sulfate versus placebo on the prevention of atrial fibrillation post cardiac surgery.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24637

Enrollment

812

Registered

2021-10-07

Start date

2022-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation

Interventions

Magnesium sulfate administration (preceded by a bolus based on serum measurement) initiated directly post induction of anesthesia until ICU discharge.

Eligibility

Inclusion criteria

Inclusion criteria: - Elective cardiac surgery (valve surgery and/or CABG) - 18 years and above

Exclusion criteria

Exclusion criteria: - History of atrial fibrillation (AF) and atrial flutter - Concomitant procedures (MAZE (surgical ablation)/PVI (pulmonary vein isolation)) - Pre-existing severe renal impairment (eGFR0.1 mcg/kg/min) - Third-degree heart block without pacemaker in situ

Design outcomes

Primary

Measure	Time frame
Newly diagnosed AF over a period of 5 minutes or longer	—

Secondary

Measure	Time frame
1. 28-day AF post-surgery. 2. Length of Hospital Stay (LOHS) and ICU LOS 3. Duration of mechanical ventilation 4. Duration of inotropic or vasopressor support 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.	—

Contacts

Public ContactJeroen Ludikhuize

HagaZiekenhuis

j.ludikhuize@hagaziekenhuis.nl070-2100000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)