Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm
Recruiting now · Phase 3
Conditions studied: Ventricular Arrhythmias and Cardiac Arrest
In brief
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)
Key facts
- Study ID
- NCT06835491
- Run by
- Versailles Hospital
- People needed
- 674
- Starts
- 2025-11-06
- Expected to finish
- 2027-03-15
- Last updated by the study team
- 2025-12-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- CH Cotentin — Valognes, France (enrolling)
- Chu Angers — Angers, France (enrolling)
- CH annecy genevois — Annecy, France (enrolling)
- Ch Argenteuil — Argenteuil, France (enrolling)
- CH Mondor — Aurillac, France (enrolling)
- CHU Brest — Brest, France (enrolling)
- CH Brive — Brive-la-Gaillarde, France (enrolling)
- CHU Poitiers — Poitiers, France (enrolling)
- Chu Strasbourg — Strasbourg, France (enrolling)
- CHI Toulon — Toulon, France (enrolling)
- Chu Toulouse — Toulouse, France (enrolling)
- Chi Nord Ardennes — Charleville-Mézières, France (enrolling)
- CHSF — Corbeil-Essonnes, France (enrolling)
- CHD vendée — La Roche-sur-Yon, France (enrolling)
- CH la rochelle — La Rochelle, France (enrolling)
- Hcl — Lyon, France (enrolling)
- Ap Hm — Marseille, France (enrolling)
- Hopital Cartier — Massy, France (enrolling)
- Hoptial Mulhouse — Mulhouse, France (enrolling)
- Clinique Ambroise Paré — Neuilly-sur-Seine, France (enrolling)
- CHU Nice -MIR Archet — Nice, France (enrolling)
- CHU Nice -MIR Pasteur — Nice, France (enrolling)
- Chu Orléans — Orléans, France (enrolling)
- CHU Cochin — Paris, France (enrolling)
- Hopital saint joseph — Paris, France (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.