Status:
RECRUITING
Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm
Lead Sponsor:
Versailles Hospital
Conditions:
Ventricular Arrhythmias and Cardiac Arrest
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion Criteria:
- Patient aged ≥ 18 years
- Admitted in intensive care unit
- Out-of-hospital cardiac arrest with initial shockable rhythm
- Presumed cardiac or unknown cause
- Delay between ROSC and screening for randomisation < 6 hours
- Informed consent from the patient or a surrogate or deferred consent
- Affiliated to or benefiting from a social insurance
Exclusion Criteria:
- Cardiac arrest secondary to an extra-cardiac cause (suspected or confirmed)
- Indication for amiodarone decided by the physician at ICU admission
- No central venous catheter available for continuous infusion of amidoarone
- Thyroid disease under treatment
- History of cardiac conduction disorders, not treated by permanent pacemaker
- Any contra indication to amiodarone treatment
- Refractory ventricular arrhythmia or electrical storm
- Need for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) at admission
- Known limitations in therapy and Do Not Resuscitate-order
- Moribund patient due to pre-arrest history (estimated life expectancy < 3 months)
- Pregnant or breastfeeding women
- Patient needing a nadolol treatment due to QT long syndrome or catecholaminergic polymorphic ventricular tachycardia
- Patient with known pulmonary fibrosis
- Patient with known interstitial lung disease
Key Trial Info
Start Date :
November 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2027
Estimated Enrollment :
674 Patients enrolled
Trial Details
Trial ID
NCT06835491
Start Date
November 6 2025
End Date
March 15 2027
Last Update
December 23 2025
Active Locations (29)
Enter a location and click search to find clinical trials sorted by distance.
1
Chu Amiens
Amiens, France
2
Chu Angers
Angers, France
3
CH annecy genevois
Annecy, France
4
Ch Argenteuil
Argenteuil, France