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.
Versailles Hospital
674 participants
Nov 6, 2025
INTERVENTIONAL
Conditions
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)
Eligibility
Inclusion Criteria7
- 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 Criteria14
- 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
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Interventions
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.
Locations(29)
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NCT06835491