Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy

Cardiac Arrest Clinical Trial

Official title:

A Pilot Randomized Controlled Trial to Compare Fixed Versus Escalating Energy Regimens for Biphasic Waveform Defibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212992
• Other study ID #: 2001266-01H
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: January 23, 2017
• Start date: March 2001
• Est. completion date: July 2006

Study information

• Verified date: January 2017
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2006
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Procedure:
• fixed versus escalating biphasic defibrillation

Locations

Country	Name	City	State
Canada	Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Stiell IG, Walker RG, Nesbitt LP, Chapman FW, Cousineau D, Christenson J, Bradford P, Sookram S, Berringer R, Lank P, Wells GA. BIPHASIC Trial: a randomized comparison of fixed lower versus escalating higher energy levels for defibrillation in out-of-hosp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful conversion to an organized heart rhythm
Secondary	Survival to hospital discharge
Secondary	Resuscitation for survival to one hour
Secondary	Neurologic function
Secondary	Removal of ventricular fibrillation (VF) in 5 seconds
Secondary	Return of spontaneous circulation
Secondary	Survival to 24 hours