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Aminophylline in Bradyasystolic Cardiac Arrest

Aminophylline in Bradyasystolic Cardiac Arrest: A Randomized Placebo-Controlled Trial

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00312273
Enrollment
966
Registered
2006-04-07
Start date
2001-01-31
Completion date
2004-07-31
Last updated
2006-07-27

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

Conditions

Cardiac Arrest

Keywords

Heart Arrest, Cardiopulmonary Resuscitation, Aminophylline, Bradycardia, Humans, Emergency Medical Services

Brief summary

The purpose of this study is to evaluate the effect of aminophylline in patients with out-of-hospital bradyasystolic cardiac arrest.

Detailed description

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.

Interventions

DRUGAminophylline (250mg IV +/- a second dose of 250mg IV)

Sponsors

Heart and Stroke Foundation of Canada
CollaboratorOTHER
Vancouver Coastal Health Research Institute
CollaboratorOTHER
Vancouver General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Cardiac arrest * Bradyasystole either as the presenting rhythm or as a rhythm developing during the course of the resuscitation * Endotracheally intubated and ventilated with 100% oxygen * Intravenous (IV) access established * Bradyasystolic without palpable pulses after 1 mg of epinephrine and 3 mg of atropine.

Exclusion criteria

* A do-not-resuscitate directive * Pregnancy * Evidence of hemorrhage, trauma or hypothermia as a cause of the cardiac arrest * Renal dialysis * Theophylline hypersensitivity * Patients taking an oral theophylline product * Resuscitations directed by a paramedic student under practicum supervision

Design outcomes

Primary

MeasureTime frame
The return of spontaneous circulation (ROSC), defined as the development of a palpable pulse of any duration.

Secondary

MeasureTime frame
ROSC duration by survival analysis
Survival to hospital admission
Survival to hospital discharge
Length of hospital stay
Maximum duration of ROSC (the duration of the longest episode of sustained pulse return)
Seizures in the first 24 hours after study drug administration
Neurologic outcome
Proportion of subjects receiving one versus two doses of study drug
Proportion of subjects achieving ROSC with initial-rhythm bradyasystole versus bradyasystole which developed after paramedic arrival.
Non-sinus tachyarrhythmias in the first 24 hours after study drug administration

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 11, 2026