The efficacy of amiodarone compared to the efficacy of adrenaline for the treatment of cardiac arrest.

Adrenaline versus amiodarone for out of hospital cardiac arrest due to shockable rhythms (ventricular fibrillation and pulseless ventricular tachycardia) - ADRAMIO. A randomized, double blind, multicentre study. - ADRAMIO

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004317-40-DK

Enrollment

800

Registered

2014-02-21

Start date

2014-06-23

Completion date

Unknown

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 Leve

Interventions

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 Co

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. ;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.	—

Measure

Time frame

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. ;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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Denmark

Contacts

Public ContactThe Heart Centre

Rigshospitalet

redpecini@icloud.com4535456397

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026