Aminophylline in Bradyasystolic Cardiac Arrest

This study has been completed.
Sponsor:
Collaborators:
Heart and Stroke Foundation of Canada
Vancouver Coastal Health Research Institute
Information provided by:
Vancouver General Hospital
ClinicalTrials.gov Identifier:
NCT00312273
First received: April 5, 2006
Last updated: July 26, 2006
Last verified: September 2003
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Aminophylline in Bradyasystolic Cardiac Arrest: A Randomized Placebo-Controlled Trial

Resource links provided by NLM:


Further study details as provided by Vancouver General Hospital:

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

Secondary Outcome Measures:
  • Maximum duration of ROSC (the duration of the longest episode of sustained pulse return)
  • ROSC duration by survival analysis
  • Survival to hospital admission
  • Survival to hospital discharge
  • Length of hospital stay
  • Non-sinus tachyarrhythmias in the first 24 hours after study drug administration
  • 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.

Estimated Enrollment: 966
Study Start Date: January 2001
Estimated Study Completion Date: July 2004
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312273

Locations
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
Investigators
Principal Investigator: Riyad B Abu Laban, MD, MHSc Department of Emergency Medicine, Vancouver General Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00312273     History of Changes
Other Study ID Numbers: 20F35869
Study First Received: April 5, 2006
Last Updated: July 26, 2006
Health Authority: Canada: Health Canada

Keywords provided by Vancouver General Hospital:
Heart Arrest
Cardiopulmonary Resuscitation
Aminophylline
Bradycardia
Humans
Emergency Medical Services

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Aminophylline
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Protective Agents

ClinicalTrials.gov processed this record on July 28, 2014