Clinical trial NCT06835491: Prophylactic Anti-aRrhythmic Therapy with Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest with Initial Shockable Rhythm
Official title: Prophylactic Anti-aRrhythmic Therapy with Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest with Initial Shockable Rhythm.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Ventricular Arrhythmias and Cardiac Arrest
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 674
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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 criteria: 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 outcomes:
measure: Rate of Mortality and severe ventricular arrhythmia
timeFrame: 30 days
Secondary outcomes:
measure: outcomes related with cardiac events
timeFrame: 90 days
measure: outcomes related with mortality
timeFrame: 90 days
measure: Duration of invasive mechanical ventilation
timeFrame: 90 days
measure: Number of participants with outcomes related with amiodorane side effects
timeFrame: 5 days
measure: Neurological outcome
timeFrame: 90 days
measure: Duration vasopressor infusion
timeFrame: 90 days
measure: Length of ICU stay
timeFrame: 90 days
measure: Length of stay in hospital
timeFrame: 90 days
measure: Dose of the anti-arrhythmic drugs
timeFrame: 90 days
measure: Number of days of anti-arrhythmic drugs
timeFrame: 90 days
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens
city: Angers
country: France
facility: Chu Angers
city: Annecy
country: France
facility: CH annecy genevois
city: Argenteuil
country: France
facility: Ch Argenteuil
city: Aurillac
country: France
facility: CH Mondor
city: Brest
country: France
facility: CHU Brest
city: Brive-la-Gaillarde
country: France
facility: CH Brive
city: Caen
country: France
facility: Chu Caen
city: Charleville-Mézières
country: France
facility: Chi Nord Ardennes
city: Corbeil-Essonnes
country: France
facility: CHSF
city: La Roche-sur-Yon
country: France
facility: CHD vendée
city: La Rochelle
country: France
facility: CH la rochelle
city: Lyon
country: France
facility: Hcl
city: Marseille
country: France
facility: Ap Hm
city: Massy
country: France
facility: Hopital Cartier
city: Montreuil
country: France
facility: chi Gregoire
city: Mulhouse
country: France
facility: Hoptial Mulhouse
city: Nantes
country: France
facility: CHU Nantes
city: Neuilly-sur-Seine
country: France
facility: Clinique Ambroise Paré
city: Nice
country: France
facility: CHU Nice -MIR Archet
city: Nice
country: France
facility: CHU Nice -MIR Pasteur
city: Orléans
country: France
facility: Chu Orléans
city: Paris
country: France
facility: CHU Cochin
city: Paris
country: France
facility: Hopital saint joseph
city: Poitiers
country: France
facility: CHU Poitiers
city: Strasbourg
country: France
facility: Chu Strasbourg
city: Toulon
country: France
facility: CHI Toulon
city: Toulouse
country: France
facility: Chu Toulouse
city: Valognes
country: France
facility: CH Cotentin
Study officials:
References: