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Aminophylline in Bradyasystolic Cardiac Arrest

NCT ID: NCT00312273

Last Updated: 2006-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

966 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2004-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cardiac Arrest

Keywords

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Heart Arrest Cardiopulmonary Resuscitation Aminophylline Bradycardia Humans Emergency Medical Services

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Stroke Foundation of Canada

OTHER

Sponsor Role collaborator

Vancouver Coastal Health Research Institute

OTHER

Sponsor Role collaborator

Vancouver General Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Riyad B Abu Laban, MD, MHSc

Role: PRINCIPAL_INVESTIGATOR

Department of Emergency Medicine, Vancouver General Hospital

Locations

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Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
PMID: 16698410 (View on PubMed)

Other Identifiers

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20F35869

Identifier Type: -

Identifier Source: org_study_id