A Phase 3 interventional study of Amiodarone in Ventricular Arrhythmias and Cardiac Arrest, sponsored by Versailles Hospital. Recruiting at 29 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Versailles Hospital · Phase 3, Interventional, and Prevention
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)
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's planned enrollment of 674 is above the median of 100 across 557 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →Versailles Hospital is the lead sponsor of 74 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Rate of Mortality and severe ventricular arrhythmia
The primary endpoint is a composite of 30-day (starting from inclusion) all-cause mortality and occurrence of severe in-hospital ventricular arrhythmia, defined by ventricular fibrillation and/or ventricular tachycardia requiring intervention occurring between inclusion and hospital discharge (or 30-day whichever the sooner).
Time frame: 30 days
outcomes related with cardiac events
* Occurrence of ventricular fibrillation (VF) * Occurrence of ventricular tachycardia (VT) requiring or not intervention * Occurrence of atrial fibrillation (AF) and supraventricular tachycardia * Occurrence of cardiac re-arrest due to asystole
Time frame: 90 days
outcomes related with mortality
* ICU mortality * Hospital (and 30-day) mortality * Day 90 mortality
Time frame: 90 days
Duration of invasive mechanical ventilation
Time frame: 90 days
Number of participants with outcomes related with amiodorane side effects
Number of the following side effects, patients could experimente (if applicable) during amiodarone infusion: * Conduction disorders * Hemodynamic consequences * Hepatic cytolysis * Anaphylaxis
Time frame: 5 days
Neurological outcome
M-Rankin scale (the lowest score is no handicap and the highest score is death) and Glasgow Outcome Score (the lowest score is the most severe coma)
Time frame: 90 days
Duration vasopressor infusion
Time frame: 90 days
Length of ICU stay
Time frame: 90 days
Length of stay in hospital
Time frame: 90 days
Dose of the anti-arrhythmic drugs
Time frame: 90 days
Number of days of anti-arrhythmic drugs
Time frame: 90 days
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Versailles Hospital