Clinical trial
MAGNesium and Digoxin Versus AMiodarone for Fast Atrial Fibrillation in the ICU (MAGNAM Trial)
Name
3664
Description
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.
Trial arms
Trial start
2022-01-05
Estimated PCD
2025-10-31
Trial end
2026-04-30
Status
Recruiting
Phase
Early phase I
Treatment
Magnesium sulfate and then Digoxin
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.
Arms:
Experimental arm
Amiodarone
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).
Arms:
Standard of care arm
Size
200
Primary endpoint
Heart rate control (<110 beats per minute) and/or restoration of normal sinus
6 hours
ICU free days
90 days
Eligibility criteria
Inclusion Criteria: Each participant must meet all of the following inclusion criteria to participate in this study:
1. Admitted to a participating hospital ICU
2. 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)
3. Undergoing, or able to commence continuous electrocardiographic monitoring ("telemetry") as part of their routine clinical care
4. Treating physician determines the patient has clinically significant AF that requires medical treatment
Exclusion Criteria:
1. Age \<18 years
2. Palliative goals of care or expected to die in the next 12 hours
3. Fast Atrial Fibrillation (\>120/min) present for \> 48 hours
4. Treatment with digoxin or a class I or III anti-arrhythmic medication within the preceding 24 hours
5. MgSO4 dose of \> 3g IV in the last 2 hours.
6. History of high grade Atrio-Ventricular conduction block or bradyarrhythmia without pacemaker
7. 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.)
8. Recent cardiac surgery during index hospital admission
9. Known pregnancy
10. Sustained (more than 10 continuous seconds documented on a rhythm strip) ventricular arrhythmia within the past 24 hours
11. Known or suspected pre-excitation syndrome
12. Persistent hyperkalemia \> 6mmol/l despite treatment
13. Previously enrolled in the MAGNAM trial
14. Recent lung transplantation (during this admission)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Individual patient, pragmatic, comparative effectiveness, randomised, controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Blinded follow up for key outcomes', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2024-04-25
1 organization
2 products
1 indication
Organization
Sunnybrook Health Sciences CentreProduct
Magnesium sulfate + DigoxinIndication
Atrial Fibrillation New OnsetProduct
Amiodarone