Title of Trial
ALIVE (amiodarone versus lidocaine) trial

Date and citation of primary publication(s) or References
New England Journal of Medicine 2002;346:884-890.

Purpose of the Trial
The purpose of this trial is to compare intravenous amiodarone and lidocaine as an adjunct to defibrillation in victims of out-of-hospital cardiac arrest.

Study Category
Ventricular arrhythmias/Sudden Death

Patient Population
Adult patients with out-of-hospital cardiac arrest

Inclusion Criteria

• Adult patient
• Ventricular fibrillation documented
• Ventricular fibrillation resistant to 3 shocks, at least one dose of intravenous epinephrine, and a fourth shock
• Ventricular fibrillation recurring after successful initial resuscitation

Exclusion Criteria

• Trauma

Study Design
Randomized, double-blind trial of intravenous amiodarone (5 mg/kg) versus Lidocaine (1.5 mg/kg)

Primary Endpoint
Survival to hospital admission

Secondary Endpoints

• Survival to hospital discharge
• Need to administer atropine or dopamine after the administration of the study drug

Baseline Characteristics
Patient number: 347
Mean Age: 67 ± 14 years
Gender: % female; 22% females
Other characteristics: Initial cardiac rhythm: ventricular fibrillation 78%, asystole 11%, pulseless electrical activity 8%, pulseless ventricular tachycardia 1%.

Time to Follow-up
Follow-up until death or hospital discharge.

Results
After treatment with amiodarone, 22.8 percent of 180 patients survived to hospital admission, as compared with 12.0 percent of 167 patients treated with lidocaine (P=0.009; odds ratio, 2.17; 95 percent confidence interval, 1.21 to 3.83). There were no differences between the treatment groups in the proportions of patients who needed treatment of bradycardia with atropine, pressor treatment with dopamine or in the proportions receiving open-label lidocaine.

Sponsor
Wyeth-Ayerst Laboratories

Trial Status: Completed

Review written by Samir Saba, MD