RecruitingPhase 3NCT05287191

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)

Sponsor

Sunnybrook Health Sciences Centre

Enrollment

200 participants

Start Date

Jan 5, 2022

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation New Onset

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called MAGNAM) compares two drugs — magnesium sulfate and amiodarone — for treating fast heart rate caused by atrial fibrillation (AFib) in critically ill patients in the ICU. Both drugs are already used clinically, but this trial aims to determine which works better and with fewer side effects in the ICU setting. **You may be eligible if...** - You are 18 or older and are admitted to an ICU - You have a new episode of atrial fibrillation with a heart rate above 120 beats per minute, confirmed by an ECG - Your doctor has decided medical treatment for the AFib is needed - You are being monitored with continuous heart rhythm monitoring **You may NOT be eligible if...** - Your fast AFib has been present for more than 48 hours - You were recently treated with certain anti-arrhythmic medications (digoxin, class I or III drugs) within the past 24 hours - You have a known high-degree heart block without a pacemaker - You are pregnant - You have certain conditions that make amiodarone or magnesium risky (e.g., known amiodarone toxicity, myasthenia gravis, thyroid disease, cirrhosis) - You have recently had heart surgery during this admission Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMagnesium 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.

DRUGAmiodarone

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).