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Peri-operative Magnesium infusion to Prevent Atrial fibrillation Evaluated.

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54180
Enrollment
530
Registered
2022-04-08
Start date
2022-08-03
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

atrial fibrillation cardiac arrhythmia

Interventions

Patients will be randomized to receive MgSO4 (bolus of 10 mmol and continuous infusion of 3 mmol/hour MgSO4 depending on serum Mg2+ level or Ringer*s lactate initiated directly post induction of ane

Sponsors

HagaZiekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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) or atrial flutter - Concomitant rhythm associated procedures (MAZE (surgical ablation)/PVI (pulmonary vein isolation)) - Pre-existing severe renal impairment (eGFR0.1 mcg/kg/min) - Development of third-degree heart block during index admission or pre-existing 3rd degree heart block without pacemaker presence.

Design outcomes

Primary

MeasureTime frame
Measurement of the incidence patients with POAF in the first 7 days post-surgery has been defined as primary endpoint.

Secondary

MeasureTime frame
Secondary endpoints include duration of POAF, peak heart rate during POAF, Length of Hospital stay (LOHS) and ICU Length Of Stay (LOS), duration of mechanical ventilation, inotropic and/or vasopressor support, combined outcome of 28-day mortality, stroke, pulmonary embolism, delirium (requiring anti-psychotic medication), infection requiring antibiotics and POAF.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)