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Clinical Trials in France / NCT06835491
Recruiting Phase 3

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

NCT06835491 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2025-11-06
Last updated
2025-12-23

Condition(s) studied

Ventricular Arrhythmias and Cardiac Arrest

Investigational drug(s) / intervention(s)

Amiodarone →

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patient aged ≥ 18 years 2. Admitted in intensive care unit 3. Out-of-hospital cardiac arrest with initial shockable rhythm 4. Presumed cardiac or unknown cause 5. Delay between ROSC and screening for randomisation \< 6 hours 6. Informed consent from the patient or a surrogate or deferred consent 7. Affiliated to or benefiting from a social insurance Exclusion Criteria: 1. Cardiac arrest secondary to an extra-cardiac cause (suspected or confirmed) 2. Indication for amiodarone decided by the physician at ICU admission 3. No central venous catheter available for continuous infusion of amidoarone 4. Thyroid disease under treatment 5. History of cardiac conduction disorders, not treated by permanent pacemaker 6. Any contra indication to amiodarone treatment 7. Refractory ventricular arrhythmia or electrical storm 8. Need for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) at admission 9. Known limitations in therapy and Do Not Resuscitate-order 10. Moribund patient due to pre-arrest history (estimated life expectancy \< 3 months) 11. Pregnant or breastfeeding women 12. Patient needing a nadolol treatment due to QT long syndrome or catecholaminergic polymorphic ventricular tachycardia 13. Patient with known pulmonary fibrosis 14. Patient with known interstitial lung disease

Primary outcome measure(s)

Trial sites (29)

FacilityCityRegionStatus
Chu Amiens Amiens France Not Yet Recruiting
Chu Angers Angers France Recruiting
CH annecy genevois Annecy France Recruiting
Ch Argenteuil Argenteuil France Recruiting
CH Mondor Aurillac France Recruiting
CHU Brest Brest France Recruiting
CH Brive Brive-la-Gaillarde France Recruiting
Chu Caen Caen France Not Yet Recruiting
Chi Nord Ardennes Charleville-Mézières France Recruiting
CHSF Corbeil-Essonnes France Recruiting
CHD vendée La Roche-sur-Yon France Recruiting
CH la rochelle La Rochelle France Recruiting
Hcl Lyon France Recruiting
Ap Hm Marseille France Recruiting
Hopital Cartier Massy France Recruiting
chi Gregoire Montreuil France Not Yet Recruiting
Hoptial Mulhouse Mulhouse France Recruiting
CHU Nantes Nantes France Not Yet Recruiting
Clinique Ambroise Paré Neuilly-sur-Seine France Recruiting
CHU Nice -MIR Archet Nice France Recruiting
CHU Nice -MIR Pasteur Nice France Recruiting
Chu Orléans Orléans France Recruiting
CHU Cochin Paris France Recruiting
Hopital saint joseph Paris France Recruiting
CHU Poitiers Poitiers France Recruiting
Chu Strasbourg Strasbourg France Recruiting
CHI Toulon Toulon France Recruiting
Chu Toulouse Toulouse France Recruiting
CH Cotentin Valognes France Recruiting

More Versailles Hospital trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06835491 on ClinicalTrials.gov ↗ ← All trials in France