The efficacy of amiodarone compared to the efficacy of adrenaline for the treatment of cardiac arrest.
Phase 1
- Conditions
- Out of hospital cardiac arrest due to ventricular fibrillation.MedDRA version: 17.0Level: LLTClassification code 10047293Term: Ventricular fibrillation paroxysmalSystem Organ Class: 100000004849MedDRA version: 17.0Level: LLTClassification code 10066685Term: Recurrent ventricular fibrillationSystem Organ Class: 100000004849MedDRA version: 17.0Level: LLTClassification code 10034048Term: Paroxysmal ventricular fibrillationSystem Organ Class: 100000004849MedDRA version: 17.0Level: LLTClassification code 10047292Term: Ventricular fibrillation paroxysmSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-004317-40-DK
- Lead Sponsor
- The Heart Centre, Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
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
Exclusion Criteria
•OHCA which is not due to ventricular fibrillation (asystole, pulseless electrical activity)
•VF/VT due to trauma, including chest trauma
•In-hospital cardiac arrest
•obvious significant internal bleeding
•known neurological impairment
•known pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br><br>;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.;Primary end point(s): Survival to hospital discharge.;Timepoint(s) of evaluation of this end point: Up to one month.
- Secondary Outcome Measures
Name Time Method 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.<br><br>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.<br><br>2. Time from first contact to Emergency Medical Service to the return of the spontaneous circulation - One hour.