Cardiac Arrest Clinical Trial
Official title:
Aminophylline in Bradyasystolic Cardiac Arrest: A Randomized Placebo-Controlled Trial
Verified date | September 2003 |
Source | Vancouver General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
The purpose of this study is to evaluate the effect of aminophylline in patients with out-of-hospital bradyasystolic cardiac arrest.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Vancouver General Hospital | Heart and Stroke Foundation of Canada, Vancouver Coastal Health Research Institute |
Canada,
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
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. |
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