MAGNAM Trial, Magnesium Versus Amiodarone in AF in Critical Care

• Status: Recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

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( 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Collaborator: Sunnybrook Research Institute
• Treatments: Amiodarone; Digoxin; Magnesium Sulfate

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 AF with HR >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 AF (>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 AV 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 Myaesthenia 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)