COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Aminophylline in Bradyasystolic Cardiac Arrest

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00312273
Recruitment Status : Completed
First Posted : April 7, 2006
Last Update Posted : July 27, 2006
Heart and Stroke Foundation of Canada
Vancouver Coastal Health Research Institute
Information provided by:
Vancouver General Hospital

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

Condition or disease Intervention/treatment Phase
Cardiac Arrest Drug: Aminophylline (250mg IV +/- a second dose of 250mg IV) Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 966 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Aminophylline in Bradyasystolic Cardiac Arrest: A Randomized Placebo-Controlled Trial
Study Start Date : January 2001
Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

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

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00312273

Layout table for location information
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
Vancouver General Hospital
Heart and Stroke Foundation of Canada
Vancouver Coastal Health Research Institute
Layout table for investigator information
Principal Investigator: Riyad B Abu Laban, MD, MHSc Department of Emergency Medicine, Vancouver General Hospital
Publications of Results:
Layout table for additonal information Identifier: NCT00312273    
Other Study ID Numbers: 20F35869
First Posted: April 7, 2006    Key Record Dates
Last Update Posted: July 27, 2006
Last Verified: September 2003
Keywords provided by Vancouver General Hospital:
Heart Arrest
Cardiopulmonary Resuscitation
Emergency Medical Services
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Protective Agents