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titlelines ARREST Clinical Trial

Title of Trial
ARREST trial

Date and citation of primary publication(s) or References
New England Journal of Medicine 1999 Sept. 16;341(12):871-878

Purpose of the Trial
The purpose of the trial is to test the hypothesis that amiodarone (300 mg IV) compared to placebo improves the rate of successful cardiac resuscitation after out-of-hospital cardiac arrest.

Study Category
Ventricular arrhythmias/Sudden Death

Patient Population
Adult victims of out-of-hospital cardiac arrest in Seatle and suburban King county, Washington, USA.

Inclusion Criteria

  • Adult patients
  • Ventricular fibrillation or pulseless ventricular tachycardia persisting after 3 or more precordial shocks.

Exclusion Criteria

  • Traumatic arrest
  • Spontaneous conversion of the arrhythmia
  • Patient on amiodarone

Study Design
Randomized, double-blind, placebo-controlled study

Primary Endpoint
Hospital admission with spontaneously perfusing rhythm

Secondary Endpoints

  • Adverse effects
  • Number of precordial shocks required after amiodarone or placebo
  • Total duration of resuscitation
  • Need for additional anti-arrhythmic drugs

Baseline Characteristics
Patient number: 504
Mean Age: 65 ± 14 years
Gender: % female; 23% females
Other characteristics: 84% of patients had VF as their initial rhythm and 16% had asystole or pulseless electrical activity.

Years to Follow-up

The follow-up period ended with death or hospital discharge.

Results
Intravenous amiodarone (300 mg), given after at least 3 precordial shocks during the resuscitation of victims of out-of-hospital cardiac arrest, increases the rate of survival to hospital admission (44% versus 34%, p=0.03; adjusted odd ratio = 1.6; confidence interval = 1.1 - 2.4) compared to placebo. The study was underpowered to detect differences in survival to hospital discharge. Patients in the amiodarone group were more likely to exhibit hypotension (59% versus 48%, p=0.04) or bradycardia (41% versus 25%, p=0.004) after receiving the study drug.

Sponsors

  • Medic One Foundation
  • Wyeth-Ayerst Laboratories

Trial Status: Completed

Review written by Samir Saba, MD

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