NCT06835491

Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm

Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 674 (estimated)
• Sponsor: Versailles Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine if prophylactic administration of amiodarone for 72 hours in critically ill patients admitted after an OHCA with shockable rhythm, with a confirmed or a presumed cardiac cause, decreases the incidence of a composite endpoint of 30-day (starting from inclusion) all-cause mortality and/or severe in-hospital ventricular arrhythmia recurrence (ventricular fibrillation and/or ventricular tachycardia requiring intervention including re-arrest)

Conditions

• Ventricular Arrhythmias and Cardiac Arrest

Interventions

Type	Name	Description
DRUG	Amiodarone	Initial loading dose of 300mg over 30 minutes in 250ml of glucose 5% solution. Continuous amiodarone infusion will be administered for 72 hours at a dose of 10 mg/kg without exceeding 900 mg/24h.

Timeline

• Start date: 2025-11-06
• Primary completion: 2027-01-15
• Completion: 2027-03-15
• First posted: 2025-02-19
• Last updated: 2025-12-23

Locations

29 sites across 1 country: France