Cardiac Arrest Clinical Trial
Official title:
Aminophylline in Bradyasystolic Cardiac Arrest: A Randomized Placebo-Controlled Trial
The purpose of this study is to evaluate the effect of aminophylline in patients with out-of-hospital bradyasystolic cardiac arrest.
Out-of-hospital cardiac arrest treated by emergency medical services has an estimated
incidence of 54.99 per 100,000 person years, which translates to some 155,000 episodes
annually in the United States. Bradyasystole is the first recorded rhythm in up to 52
percent of cardiac arrests, and many additional patients with an initial cardiac arrest
rhythm of ventricular fibrillation deteriorate to bradyasystole after defibrillation
efforts. Survival to hospital discharge occurs in less than 3 percent of patients presenting
with bradyasystole; however, due to its frequency, this rhythm accounts for over 17 percent
of all cardiac arrest survivors. As a result, even a small improvement in survival from
bradyasystolic cardiac arrest would result in thousands of lives saved annually.
Adenosine is an endogenous purine nucleoside that depresses the sinoatrial node, blocks
atrioventricular conduction, inhibits the pacemaker activity of the His-Purkinje system and
attenuates the effects of catecholamines. Since adenosine is produced and released by
myocardial cells during ischemia and hypoxia, it may be a reversible factor in the etiology
or perpetuation of bradyasystole. Aminophylline is a competitive antagonist of adenosine.
The use of aminophylline for bradycardia and heart block has been described, and a number of
anecdotal reports and small studies have been published on the use of aminophylline in
cardiac arrest. We undertook this study to evaluate the effect of aminophylline during
cardiopulmonary resuscitation (CPR) of patients with out-of-hospital bradyasystolic cardiac
arrest unresponsive to initial therapy.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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