Comparing Magnesium and Amiodarone for Atrial Fibrillation in Critical Care
MAGNesium and Digoxin Versus AMiodarone for Fast Atrial Fibrillation in the ICU (MAGNAM Trial)
This study is testing whether high-dose magnesium followed by digoxin works better than amiodarone for treating rapid atrial fibrillation in critically ill patients.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 5 sites (Toronto, Ontario and 4 other locations) |
| Trial ID | NCT05287191 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multi-centre, non-blinded, randomized controlled trial that aims to compare the effectiveness of high-dose Magnesium Sulphate followed by Digoxin against Amiodarone as the first-line treatment for new onset rapid atrial fibrillation in critically ill patients. Patients will be enrolled from Critical Care Units and assessed for eligibility based on specific criteria at the onset of fast atrial fibrillation. The study will evaluate the success rate in restoring normal heart rhythm and the speed of resolution of critical illness over a two-year period with a target sample size of 200 patients.
Who should consider this trial
Good fit: Ideal candidates are critically ill patients admitted to an ICU with newly documented fast atrial fibrillation requiring medical treatment.
Not a fit: Patients with palliative goals of care or those expected to die within 12 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide a more effective treatment option for critically ill patients experiencing rapid atrial fibrillation.
How similar studies have performed: Other studies have explored similar treatment strategies, but this specific comparison of Magnesium versus Amiodarone in critical care is novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Toronto, Ontario and 4 other locations
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
- St Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
- University Health Network - Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
- University Health Network - Toronto Western Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Brian H Cuthbertson, MD — Sunnybrook Health Sciences Centre
- Study coordinator: Brian H Cuthbertson, MD
- Email: brian.cuthbertson@sunnybrook.ca
- Phone: 416 480 6100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.