Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm.
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
Chu Amiens
NOT_YET_RECRUITING
Amiens
Chu Angers
RECRUITING
Angers
CH annecy genevois
RECRUITING
Annecy
Ch Argenteuil
RECRUITING
Argenteuil
CH Mondor
RECRUITING
Aurillac
CHU Brest
RECRUITING
Brest
CH Brive
RECRUITING
Brive-la-gaillarde
Chu Caen
NOT_YET_RECRUITING
Caen
Chi Nord Ardennes
RECRUITING
Charleville-mézières
CHSF
RECRUITING
Corbeil-essonnes
CHD vendée
RECRUITING
La Roche-sur-yon
CH la rochelle
RECRUITING
La Rochelle
Hcl
RECRUITING
Lyon
Ap Hm
RECRUITING
Marseille
Hopital Cartier
RECRUITING
Massy
chi Gregoire
NOT_YET_RECRUITING
Montreuil
Hoptial Mulhouse
RECRUITING
Mulhouse
CHU Nantes
NOT_YET_RECRUITING
Nantes
Clinique Ambroise Paré
RECRUITING
Neuilly-sur-seine
CHU Nice -MIR Archet
RECRUITING
Nice
CHU Nice -MIR Pasteur
RECRUITING
Nice
Chu Orléans
RECRUITING
Orléans
CHU Cochin
RECRUITING
Paris
Hopital saint joseph
RECRUITING
Paris
CHU Poitiers
RECRUITING
Poitiers
Chu Strasbourg
RECRUITING
Strasbourg
CHI Toulon
RECRUITING
Toulon
Chu Toulouse
RECRUITING
Toulouse
CH Cotentin
RECRUITING
Valognes
Contact Information
Primary
Sandrine Roux
sroux@ght78sud.fr
0139239777
Time Frame
Start Date:2025-11-06
Estimated Completion Date:2027-03-15
Participants
Target number of participants:674
Treatments
Experimental: 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.