NCT00212992CompletedPhase 3
A Pilot Randomized Controlled Trial to Compare Fixed Versus Escalating Energy Regimens for Biphasic Waveform Defibrillation
Ottawa Hospital Research Institute2 sites in 1 country221 target enrollmentStarted: March 2001Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 221
- Locations
- 2
- Primary Endpoint
- Successful Conversion to an Organized Heart Rhythm
Study Overview
Brief Summary
This study will compare the effect of constant low-level energy [150 joules] to an escalating energy [200-300-360 joules] regimen of biphasic waveform defibrillation on multiple patient outcomes.
Detailed Description
This pilot, which will enroll 200 subjects, will allow a reasonable estimate of effect size and this will, in turn, allow for the accurate design and planning of a definitive randomized controlled trial. The following outcomes will be evaluated:
- Important Clinical Outcomes:
- Successful conversion,
- Resuscitation to one hour,
- Survival to hospital discharge,
- Neurological function, and
- Quality of life.
- Process Outcomes:
- Number of shocks required,
- Recurrences of VF, and
- Responsiveness to varying periods of pulselessness.
- Adverse Outcomes:
- Myocardial damage.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Witnessed cardiac arrest out-of-hospital requiring defibrillation and given by first responder using an automated external defibrillator
Exclusion Criteria
- •Terminal illness or do-not-resuscitate (DNR) status
- •No cardiopulmonary resuscitation (CPR) x 10 minutes
- •Acute trauma
- •Exsanguination
- •Cardiac arrest experienced while in hospital
Outcomes
Primary Outcomes
Successful Conversion to an Organized Heart Rhythm
Time Frame: Termination of defibrillation
Secondary Outcomes
- Survival to Hospital Discharge(30 days)
- Resuscitation for Survival to One Hour(One hour from termination of defibrillation)
- Neurologic Function(30 days)
- Return of Spontaneous Circulation(Termination of defibrillation)
- Survival to 24 Hours(24 hours)
Investigators
Study Sites (2)
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