- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00312273
Aminophylline in Bradyasystolic Cardiac Arrest
Aminophylline in Bradyasystolic Cardiac Arrest: A Randomized Placebo-Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The return of spontaneous circulation (ROSC), defined as the development of a palpable pulse of any duration.
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Secondary Outcome Measures
Outcome Measure |
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Length of hospital stay
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Maximum duration of ROSC (the duration of the longest episode of sustained pulse return)
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ROSC duration by survival analysis
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Survival to hospital admission
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Survival to hospital discharge
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Non-sinus tachyarrhythmias in the first 24 hours after study drug administration
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Seizures in the first 24 hours after study drug administration
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Neurologic outcome
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Proportion of subjects receiving one versus two doses of study drug
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Proportion of subjects achieving ROSC with initial-rhythm bradyasystole versus bradyasystole which developed after paramedic arrival.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Riyad B Abu Laban, MD, MHSc, Department of Emergency Medicine, Vancouver General Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Heart Arrest
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Purinergic Antagonists
- Purinergic Agents
- Protective Agents
- Cardiotonic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Aminophylline
Other Study ID Numbers
- 20F35869
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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