Aminophylline in Bradyasystolic Cardiac Arrest

Cardiac Arrest Clinical Trial

Official title:

Aminophylline in Bradyasystolic Cardiac Arrest: A Randomized Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312273
• Other study ID #: 20F35869
• Status: Completed
• Phase: Phase 2
• First received: April 5, 2006
• Last updated: July 26, 2006
• Start date: January 2001
• Est. completion date: July 2004

Study information

• Verified date: September 2003
• Source: Vancouver General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 966
• Est. completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

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

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Vancouver General Hospital	Heart and Stroke Foundation of Canada, Vancouver Coastal Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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-controlle — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The return of spontaneous circulation (ROSC), defined as the development of a palpable pulse of any duration.
Secondary	Maximum duration of ROSC (the duration of the longest episode of sustained pulse return)
Secondary	ROSC duration by survival analysis
Secondary	Survival to hospital admission
Secondary	Survival to hospital discharge
Secondary	Length of hospital stay
Secondary	Non-sinus tachyarrhythmias in the first 24 hours after study drug administration
Secondary	Seizures in the first 24 hours after study drug administration
Secondary	Neurologic outcome
Secondary	Proportion of subjects receiving one versus two doses of study drug
Secondary	Proportion of subjects achieving ROSC with initial-rhythm bradyasystole versus bradyasystole which developed after paramedic arrival.