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

April 5, 2006
July 26, 2006
January 2001
Not Provided
The return of spontaneous circulation (ROSC), defined as the development of a palpable pulse of any duration.
Same as current
Complete list of historical versions of study NCT00312273 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Aminophylline in Bradyasystolic Cardiac Arrest
Aminophylline in Bradyasystolic Cardiac Arrest: A Randomized Placebo-Controlled Trial

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Cardiac Arrest
Drug: Aminophylline (250mg IV +/- a second dose of 250mg IV)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
966
July 2004
Not Provided

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00312273
20F35869
Not Provided
Not Provided
Vancouver General Hospital
  • Heart and Stroke Foundation of Canada
  • Vancouver Coastal Health Research Institute
Principal Investigator: Riyad B Abu Laban, MD, MHSc Department of Emergency Medicine, Vancouver General Hospital
Vancouver General Hospital
September 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP