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Is magnesium sulphate a safe and effective treatment option for adult patients presenting with atrial fibrillation to the department of Emergency medicine?

To evaluate the efficacy of intravenous Magnesium sulfate versus intravenous Diltiazem as first line rate controlling agent in patients presenting with atrial fibrillation- A randomized control trial - MADI TRIAL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052653
Enrollment
220
Registered
2023-05-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I48- Atrial fibrillation and flutter

Interventions

Intervention1: Inj. Magnesium Sulphate: Inj. Magnesium sulphate 2gm in 100 ml normal saline slow IV over10 minutes Control Intervention1: Inj. Diltiazem: Inj. Diltiazem 20mg in 100 ml normal saline sl

Sponsors

Fluid research fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. New onset atrial fibrillation with fast ventricular rate 2. Persistent atrial fibrillation with fast ventricular rate

Exclusion criteria

Exclusion criteria: 1. Patients already on calcium channel blockers 2. Indication for electrical cardioversion 3. Known case of heart blocks 4. Known Severe hypomagnesemia or hypermagnesemia (serum Magnesium levels 5.0mg/dl) 5. Known case of Renal failure with recent creatinine > 3.0 mg/dl 6. Systolic Blood pressure 7. Altered mental status 8. Wide complex ventricular response 9. Acute myocardial infarction 10. Cardiogenic shock 11. Other arrhythmias 12. Pregnant patients 13. Acute pulmonary edema with SPO2

Design outcomes

Primary

MeasureTime frame
To reduce the ventricular rate to less than 100/min or reduction by 20% of the initial heart rate.Timepoint: 30 minutes after drug administration

Secondary

MeasureTime frame
Resolution time: time taken for the desired effect to occur after initiating the primary drugTimepoint: After 6 hours;Percentage of cases reverting back to sinus rhythm. Timepoint: After 6 hours;To assess the complications associated with use of MgSo4 and diltiazem. Incidence of hypotension, bradycardia, respiratory depression. Timepoint: After 6 hours;Outcome of the patients: a.Discharge from ED b.Admission to ICU or ward c.Discharged against medical advice Timepoint: After 6 hours;Number of drugs required for rate control apart from the study drug. Timepoint: After 6 hours;Number of patients in sinus rhythmTimepoint: After 48 hours

Countries

India

Contacts

Public ContactPriya Ganesan

Christian Medical College, Vellore

priyajyotsnav@gmail.com8903308084

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026