In patients undergoing cardiothoracic surgery, to investigate the effect of continuous (preceded by a bolus) administration of perioperative magnesium sulphate (MgSO4) on the incidence patients with POAF.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measurement of the incidence patients with POAF in the first 7 days
post-surgery has been defined as primary endpoint.
Secondary outcome
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.
Background summary
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.
Study objective
In patients undergoing cardiothoracic surgery, to investigate the effect of
continuous (preceded by a bolus) administration of perioperative magnesium
sulphate (MgSO4) on the incidence patients with POAF.
Study design
Single-center, randomized placebo-controlled trial.
Intervention
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 anesthesia until discharge from the
Intensive Care Unit (ICU). Magnesium levels in the OR and ICU are maintained
above 1 mmol/L as part of general care. Magnesium levels thresholds for the
POMPAE study are maintained between 1.5 and 2.0 mmol/L.
Study burden and risks
Magnesium is regularly administrated post-cardiac surgery to maintain a serum
level above 1 mmol/L. Adverse events regarding magnesium administrations are
rare and toxicity occurs at levels above 2.0-2.5 mmol/L. From treatment
regimens for preeclampsia, plasma levels of 2.5-3.5 mmol/L or higher are
achieved regularly. Therefore, signs of hypermagnesemia (lethargy, somnolence,
absent tendon reflexes, bradycardia, and ECG changes) will be monitored. As the
study is performed in both the operating theater and ICU and magnesium levels
are monitored regularly with toxicity generally occurring with significantly
higher than desired serum levels, the risk for participating patients is deemed
low.
Els Borst-Eilersplein 275
Den Haag 2545AA
NL
Els Borst-Eilersplein 275
Den Haag 2545AA
NL
Listed location countries
Age
Inclusion criteria
- Elective cardiac surgery (valve surgery and/or CABG)
- 18 years and above
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 >0.1
mcg/kg/min)
- Development of third-degree heart block during index admission or
pre-existing 3rd degree heart block without pacemaker presence.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| EudraCT | EUCTR2022-001393-58-NL |
| ClinicalTrials.gov | NCT05669417 |
| CCMO | NL77956.058.21 |