The POMPAE trial will investigate the effect of magnesium sulphate versus placebo on the incidence of atrial fibrillation after cardiac surgery.

Phase 1

• Conditions: Atrial fibrillation; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2022-001393-58-NL
• Lead Sponsor: Hagaziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-16
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

- Elective cardiac surgery (valve surgery and/or CABG)
- 18 years and above
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 530
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 530

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) 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
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>0.1 mcg/kg/min)
- Development of third-degree heart block during index admission or
pre-existing 3rd degree heart block without pacemaker presence.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In patients undergoing cardiothoracic surgery, to investigate the effect<br>of continuous (preceded by a bolus) administration of perioperative<br>magnesium sulphate (MgSO4) on the incidence patients with POAF.;Secondary Objective: Not applicable;Primary end point(s): Measurement of the incidence patients with POAF in the first 7 days<br>post-surgery has been defined as primary endpoint.;Timepoint(s) of evaluation of this end point: 7 days after operation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints include duration of POAF, peak heart rate<br>during POAF, Length of Hospital stay (LOHS) and ICU Length Of Stay<br>(LOS), duration of mechanical ventilation, inotropic and/or<br>vasopressor support, combined outcome of 28-day mortality, stroke,<br>pulmonary embolism, delirium (requiring anti-psychotic medication),<br>infection requiring antibiotics and POAF.<br>;Timepoint(s) of evaluation of this end point: 28 days post operation.