Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00212992
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : January 24, 2017
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Procedure: fixed versus escalating biphasic defibrillation Phase 3

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:

  1. Important Clinical Outcomes:

    • Successful conversion,
    • Resuscitation to one hour,
    • Survival to hospital discharge,
    • Neurological function, and
    • Quality of life.
  2. Process Outcomes:

    • Number of shocks required,
    • Recurrences of VF, and
    • Responsiveness to varying periods of pulselessness.
  3. Adverse Outcomes:

    • Myocardial damage.

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Pilot Randomized Controlled Trial to Compare Fixed Versus Escalating Energy Regimens for Biphasic Waveform Defibrillation
Actual Study Start Date : March 2001
Actual Primary Completion Date : September 2005
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest
U.S. FDA Resources

Primary Outcome Measures :
  1. Successful conversion to an organized heart rhythm

Secondary Outcome Measures :
  1. Survival to hospital discharge
  2. Resuscitation for survival to one hour
  3. Neurologic function
  4. Removal of ventricular fibrillation (VF) in 5 seconds
  5. Return of spontaneous circulation
  6. Survival to 24 hours

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00212992

Canada, Ontario
Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Principal Investigator: Ian Stiell, MD OHRI

Publications of Results:
Responsible Party: Ottawa Hospital Research Institute Identifier: NCT00212992     History of Changes
Other Study ID Numbers: 2001266-01H
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ottawa Hospital Research Institute:
ventricular fibrillation
heart arrest

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases