Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00312273
Other study ID # 20F35869
Secondary ID
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
Est. primary completion date
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


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.
See also
  Status Clinical Trial Phase
Recruiting NCT06048068 - Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events N/A
Recruiting NCT05558228 - Accuracy of Doppler Ultrasound Versus Manual Palpation of Pulse in Cardiac Arrest
Completed NCT03685383 - Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation N/A
Completed NCT04619498 - Effectiveness of an Interactive Cognitive Support Tablet App to Improve the Management of Pediatric Cardiac Arrest N/A
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT02352350 - Lactate in Cardiac Arrest N/A
Completed NCT03024021 - Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia
Completed NCT02247947 - Proteomics to Identify Prognostic Markers After CPR and to Estimate Neurological Outcome
Completed NCT02275234 - Care After Resuscitation
Completed NCT01972087 - Simulation Training to Improve 911 Dispatcher Identification of Cardiac Arrest N/A
Completed NCT01936597 - Prospective Study of 3 Phone Assistance Strategies to Achieve a Continuous Cardiac Massage N/A
Completed NCT01944605 - Intestinal Ischemia as a Stimulus for Systemic Inflammatory Response After Cardiac Arrest N/A
Active, not recruiting NCT01239420 - Norwegian Cardio-Respiratory Arrest Study
Completed NCT00878644 - Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial Phase 3
Completed NCT00880087 - Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial N/A
Completed NCT01191736 - Ultra-Brief Versus Brief Hands Only CPR Video Training With and Without Psychomotor Skill Practice N/A
Completed NCT00729794 - Vasopressin, Epinephrine, and Steroids for Cardiac Arrest Phase 3
Recruiting NCT00441753 - Cerebral Bloodflow and Carbondioxide Reactivity During Mild Therapeutic Hypothermia in Patients After Cardiac Arrest N/A
Completed NCT00347477 - Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest Phase 3