No registrations found.
ID
Source
Brief title
Health condition
Atrial fibrillation
Sponsors and support
Intervention
Outcome measures
Primary outcome
Newly diagnosed AF over a period of 5 minutes or longer
Secondary outcome
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.
Background summary
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.
Study objective
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).
Study design
First 28 days post-surgery
Intervention
Magnesium sulfate administration (preceded by a bolus based on serum measurement) initiated directly post induction of anesthesia until ICU discharge.
Inclusion criteria
- Elective cardiac surgery (valve surgery and/or CABG)
- 18 years and above
Exclusion criteria
- 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9810 |
| Other | METC Leiden-Den Haag-Delft. (METC LDD) : Following |