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Aminophylline in Bradyasystolic Cardiac Arrest

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Aminophylline (250mg IV +/- a second dose of 250mg IV)
Sponsored by
Vancouver General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Heart Arrest, Cardiopulmonary Resuscitation, Aminophylline, Bradycardia, Humans, Emergency Medical Services

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vancouver General Hospital

Outcomes

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.

Full Information

First Posted
April 5, 2006
Last Updated
July 26, 2006
Sponsor
Vancouver General Hospital
Collaborators
Heart and Stroke Foundation of Canada, Vancouver Coastal Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00312273
Brief Title
Aminophylline in Bradyasystolic Cardiac Arrest
Official Title
Aminophylline in Bradyasystolic Cardiac Arrest: A Randomized Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2003
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Vancouver General Hospital
Collaborators
Heart and Stroke Foundation of Canada, Vancouver Coastal Health Research Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Heart Arrest, Cardiopulmonary Resuscitation, Aminophylline, Bradycardia, Humans, Emergency Medical Services

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
966 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aminophylline (250mg IV +/- a second dose of 250mg IV)
Primary Outcome Measure Information:
Title
The return of spontaneous circulation (ROSC), defined as the development of a palpable pulse of any duration.
Secondary Outcome Measure Information:
Title
Maximum duration of ROSC (the duration of the longest episode of sustained pulse return)
Title
ROSC duration by survival analysis
Title
Survival to hospital admission
Title
Survival to hospital discharge
Title
Length of hospital stay
Title
Non-sinus tachyarrhythmias in the first 24 hours after study drug administration
Title
Seizures in the first 24 hours after study drug administration
Title
Neurologic outcome
Title
Proportion of subjects receiving one versus two doses of study drug
Title
Proportion of subjects achieving ROSC with initial-rhythm bradyasystole versus bradyasystole which developed after paramedic arrival.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riyad B Abu Laban, MD, MHSc
Organizational Affiliation
Department of Emergency Medicine, Vancouver General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16698410
Citation
Abu-Laban RB, McIntyre CM, Christenson JM, van Beek CA, Innes GD, O'Brien RK, Wanger KP, McKnight RD, Gin KG, Zed PJ, Watts J, Puskaric J, MacPhail IA, Berringer RG, Milner RA. Aminophylline in bradyasystolic cardiac arrest: a randomised placebo-controlled trial. Lancet. 2006 May 13;367(9522):1577-84. doi: 10.1016/S0140-6736(06)68694-7.
Results Reference
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Aminophylline in Bradyasystolic Cardiac Arrest

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