Perioperative magnesium infusion (maintaining a serum concentration between 1.5-2.0 mmol/L) is able to clinically significantly reduce the incidence of perioperative atrial fibrillation (POAF).
ID
Bron
Verkorte titel
Aandoening
Atrial fibrillation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Newly diagnosed AF over a period of 5 minutes or longer
Achtergrond van het onderzoek
Rationale: 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.
Objective: To investigate the effect of continuous (preceded by a bolus) administration of magnesium sulphate (Mg2SO4) in the perioperative phase on the incidence of POAF in patients undergoing cardiothoracic surgery.
Study design: Single-center, randomized placebo-controlled trial
Study population: Patient (18 years and older) undergoing elective cardiac surgery (Coronary Artery Bypass Surgery, CABG) and/or valve (any position(s)) surgery.
Intervention: Patients will be randomized to receive Mg2SO4 directly post induction of anesthesia until discharge from the Intensive Care Unit (ICU).
Main study parameters/endpoints: Measurement of the incidence of POAF in the first 7 days post-surgery has been defined as primary endpoints. Secondary endpoints include 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.
Doel van het onderzoek
Perioperative magnesium infusion (maintaining a serum concentration between 1.5-2.0 mmol/L) is able to clinically significantly reduce the incidence of perioperative atrial fibrillation (POAF).
Onderzoeksopzet
First 28 days post-surgery
Onderzoeksproduct en/of interventie
Magnesium sulfate administration (preceded by a bolus based on serum measurement) initiated directly post induction of anesthesia until ICU discharge.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Elective cardiac surgery (valve surgery and/or CABG)
- 18 years and above
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9810 |
| Ander register | METC Leiden-Den Haag-Delft. (METC LDD) : Following |