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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
674
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.
Chu Amiens
Amiens, France
NOT_YET_RECRUITINGChu Angers
Angers, France
RECRUITINGCH annecy genevois
Annecy, France
RECRUITINGCh Argenteuil
Argenteuil, France
RECRUITINGCH Mondor
Aurillac, France
RECRUITINGCHU Brest
Brest, France
RECRUITINGCH Brive
Brive-la-Gaillarde, France
RECRUITINGChu Caen
Caen, France
NOT_YET_RECRUITINGChi Nord Ardennes
Charleville-Mézières, France
RECRUITINGCHSF
Corbeil-Essonnes, France
RECRUITING...and 19 more locations
Rate of Mortality and severe ventricular arrhythmia
The primary endpoint is a composite of 30-day (starting from inclusion) all-cause mortality and occurrence of severe in-hospital ventricular arrhythmia, defined by ventricular fibrillation and/or ventricular tachycardia requiring intervention occurring between inclusion and hospital discharge (or 30-day whichever the sooner).
Time frame: 30 days
outcomes related with cardiac events
* Occurrence of ventricular fibrillation (VF) * Occurrence of ventricular tachycardia (VT) requiring or not intervention * Occurrence of atrial fibrillation (AF) and supraventricular tachycardia * Occurrence of cardiac re-arrest due to asystole
Time frame: 90 days
outcomes related with mortality
* ICU mortality * Hospital (and 30-day) mortality * Day 90 mortality
Time frame: 90 days
Duration of invasive mechanical ventilation
Time frame: 90 days
Number of participants with outcomes related with amiodorane side effects
Number of the following side effects, patients could experimente (if applicable) during amiodarone infusion: * Conduction disorders * Hemodynamic consequences * Hepatic cytolysis * Anaphylaxis
Time frame: 5 days
Neurological outcome
M-Rankin scale (the lowest score is no handicap and the highest score is death) and Glasgow Outcome Score (the lowest score is the most severe coma)
Time frame: 90 days
Duration vasopressor infusion
Time frame: 90 days
Length of ICU stay
Time frame: 90 days
Length of stay in hospital
Time frame: 90 days
Dose of the anti-arrhythmic drugs
Time frame: 90 days
Number of days of anti-arrhythmic drugs
Time frame: 90 days
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