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Completed

NCT Number: NCT00312273

Aminophylline in Bradyasystolic Cardiac Arrest

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

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

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

Secondary outcomes

  1. Maximum duration of ROSC (the duration of the longest episode of sustained pulse return)

  2. ROSC duration by survival analysis

  3. Survival to hospital admission

  4. Survival to hospital discharge

  5. Length of hospital stay

  6. Non-sinus tachyarrhythmias in the first 24 hours after study drug administration

  7. Seizures in the first 24 hours after study drug administration

  8. Neurologic outcome

  9. Proportion of subjects receiving one versus two doses of study drug

  10. Proportion of subjects achieving ROSC with initial-rhythm bradyasystole versus bradyasystole which developed after paramedic arrival.

Sponsors and collaborators

Lead sponsor

Vancouver General Hospital

Other

Collaborators

  • Heart and Stroke Foundation of Canada
  • Vancouver Coastal Health Research Institute

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2004
First posted
Apr 7, 2006
Registry last updated
Jul 27, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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