MAGNAM Trial, Magnesium Versus Amiodarone in Atrial Fibrillation in Critical Care
MAGNesium and Digoxin Versus AMiodarone for Fast Atrial Fibrillation in the ICU (MAGNAM Trial)
Sunnybrook Health Sciences Centre
200 participants
Jan 5, 2022
INTERVENTIONAL
Conditions
Summary
A multi-centre, non-blinded, comparative effectiveness, randomised controlled trial. Patients will be prospectively enrolled from Critical Care Units and will be assessed for study enrollment based on inclusion/exclusion criteria at the time of the onset of fast atrial fibrillation (AF)(irregular and often rapid heart rate). The authors hypothesize that high dose Magnesium Sulphate with the addition of Digoxin as a second line treatment will improve the success rate in returning the heart to normal rhythm as well as speed of resolution of critical illness in new onset rapid atrial fibrillation in the critically ill cared for in general ICUs.
Eligibility
Inclusion Criteria4
- Admitted to a participating hospital ICU
- A newly documented episode of fast Atrial Fibrillation with heart rate \>120/min confirmed by a 12-lead ECG assessment regardless of baseline rhythm (note- The AF can be acute or chronic diagnosis)
- Undergoing, or able to commence continuous electrocardiographic monitoring ("telemetry") as part of their routine clinical care
- Treating physician determines the patient has clinically significant AF that requires medical treatment
Exclusion Criteria14
- Age \<18 years
- Palliative goals of care or expected to die in the next 12 hours
- Fast Atrial Fibrillation (\>120/min) present for \> 48 hours
- Treatment with digoxin or a class I or III anti-arrhythmic medication within the preceding 24 hours
- MgSO4 dose of \> 3g IV in the last 2 hours.
- History of high grade Atrio-Ventricular conduction block or bradyarrhythmia without pacemaker
- Non-cardiac indication or contraindication to one of the study treatments (hypertensive disorders of pregnancy, pre-term labour, neuromuscular junction disorders i.e. known Myasthenia gravis; documented prior history of amiodarone toxicity or relative contraindication such as thyroid disease, cirrhosis, pulmonary fibrosis, etc.)
- Recent cardiac surgery during index hospital admission
- Known pregnancy
- Sustained (more than 10 continuous seconds documented on a rhythm strip) ventricular arrhythmia within the past 24 hours
- Known or suspected pre-excitation syndrome
- Persistent hyperkalemia \> 6mmol/l despite treatment
- Previously enrolled in the MAGNAM trial
- Recent lung transplantation (during this admission)
Interventions
We will test MgSO4 and then digoxin IV (in 3 divided dose) as second line therapy with amiodarone IV as third line. Digoxin will be protocolised to commence between 30 minutes and 12 hours after MgSO4 if fast Atrial Fibrillation persists as initially designated (dose 1). Undiluted IV digoxin (12 mcg/kg) will be administered in 3 divided doses (6, 3 and 3 mcg/kg) separated by approximately 6 hrs (i.e. dose 1 at 30 mins - 12 hours after MgSO4, followed by dose 2 at -6 hrs and dose 3 at the approximately 12 hrs). Patients with renal dysfunction (creatinine clearance \<60 ml/min measured by the Modification of diet in renal disease formula) will receive a reduced dose of 8 mcg/kg in 3 divided doses (4, 2, and 2 mcg/kg) separated by the same time intervals. In the trial intervention group, amiodarone will be given approximately 120 mins after digoxin if necessary whilst completing the digoxin dose. Amiodarone as a 150 mg infusion over 10 minutes followed by 900 mg over 24 hours.
We will test Amiodarone (150mg IV then 900mg IV over the next 24 hours ) as first line treatment in the standard of care group. No more than 2g MgSO4 be delivered over 2 hours maximum for this group in the first 24 hours after randomisation unless clinically indicated for measured hypomagnesaemia (a value below the index hospital laboratories lower limit of normal).
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT05287191