Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy - Full Text View

Sponsored by:	Ottawa Health Research Institute
Information provided by:	Ottawa Health Research Institute
ClinicalTrials.gov Identifier:	NCT00212992

Purpose

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	Intervention	Phase
Cardiac Arrest	Procedure: fixed versus escalating biphasic defibrillation	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Single Group Assignment, Efficacy Study
Official Title:	A Pilot Randomized Controlled Trial to Compare Fixed Versus Escalating Energy Regimens for Biphasic Waveform Defibrillation

Further study details as provided by Ottawa Health Research Institute:

Primary Outcome Measures:

Successful conversion to an organized heart rhythm

Secondary Outcome Measures:

Survival to hospital discharge
Resuscitation for survival to one hour
Neurologic function
Removal of ventricular fibrillation (VF) in 5 seconds
Return of spontaneous circulation
Survival to 24 hours

Estimated Enrollment:	200
Study Start Date:	March 2001
Estimated Study Completion Date:	July 2006

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.

Eligibility

Ages Eligible for Study:	8 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212992

Locations

Canada, Ontario
Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9

Sponsors and Collaborators

Ottawa Health Research Institute

Investigators

Principal Investigator:

Ian Stiell, MD

OHRI

More Information

Study ID Numbers:	2001266-01H
Study First Received:	September 13, 2005
Last Updated:	September 23, 2006
ClinicalTrials.gov Identifier:	NCT00212992
Health Authority:	Canada: Health Canada

Keywords provided by Ottawa Health Research Institute:

defibrillation
ventricular fibrillation
heart arrest

Study placed in the following topic categories:

Heart Diseases
Paroxysmal ventricular fibrillation
Heart Arrest
Ventricular Fibrillation

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009