Adrenaline versus amiodarone for out of hospital cardiac arrest due to shockable rhythms (ventricular fibrillation and pulseless ventricular tachycardia) - ADRAMIO.

INTERVENTION: Trade Name: Cordarone Pharmaceutical Form: Injection INN or Proposed INN: AMIODARONE HYDROCHLORIDE CAS Number: 19774‐82‐4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intravenous bolus use (Noncurrent) Trade Name: Adrenalin Pharmaceutical Form: Injection INN or Proposed INN: ADRENALINE CAS Number: 51‐43‐4 Other descriptive name: ADRENALINE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1‐ Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intravenous bolus use (Noncurrent) CONDITION: Out of hospital cardiac arrest due to ventricular fibrillation. ; MedDRA version: 17.0 Level: LLT Classification code 10047293 Term: Ventricular fibrillation paroxysmal System Organ Class: 100000004849 ; MedDRA version: 17.0 Level: LLT Classification code 10066685 Term: Recurrent ventricular fibrillation System Organ Class: 100000004849 ; MedDRA version: 17.0 Level: LLT Classification code 10034048 Term: Paroxysmal ventricular fibrillation System Organ Class: 100000004849 ; MedDRA version: 17.0 Level: LLT Classification code 10047292 Term: Ventricular fibrillation paroxysm System Organ Class: 100000004849 Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: To investigate whether the administration of a larger total dosage of amiodarone is superior to a combination of adrenaline and low dosage amiodarone for treatment of out of hospital cardiac arrest due to ventricular fibrillation in regard to survival to hospital discharge. ; ; Primary end point(s): Survival to hospital discharge. Secondary Objective: To investigate whether the administration of a larger total dosage of amiodarone is superior to a combination of adrenaline and low dosage amiodarone for treatment of out of hospital cardiac arrest due to ventricular fibrillation in regard to functional neurologic status. Timepoint(s) of evaluation of this end point: Up to one month. SECONDARY OUTCOME: Secondary end point(s): 1.Functional neurologic status six months after hospital discharge measured on the Cerebral Performance Category (CPC). CPC scores are defined as: I – normal function, II – mild to moderate disability, III – severe disability, IV – vegetative state, and V – dead.; ; 2.Time from first contact to Emergency Medical Service to the return of the spontaneous circulation. Timepoint(s) of evaluation of this end point: 1. Functional neurologic status six months after hospital discharge ‐ Six months.; ; 2. Time from first contact to Emergency Medical Service to the return of the spontaneous circulation ‐ One hour. INCLUSION CRITERIA: Individuals that are at least 18 years old and who have suffer cardiac arrest, which has occurred out of the hospital and is due to ventricular fibrillation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300