NCT00212992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
18.8 years until next milestone

Results Posted

Study results publicly available

April 25, 2025

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

4.5 years

First QC Date

September 13, 2005

Results QC Date

March 21, 2025

Last Update Submit

April 24, 2025

Conditions

Cardiac Arrest

Keywords

defibrillationventricular fibrillationheart arrest

Outcome Measures

Primary Outcomes (1)

  • Successful Conversion to an Organized Heart Rhythm

    Termination of defibrillation

Secondary Outcomes (5)

  • 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

Study Arms (2)

Fixed lower-energy

ACTIVE COMPARATOR

Out-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks

Procedure: Fixed lower-energy defibrillation

Escalating higher-Energy

ACTIVE COMPARATOR

Out-of-hospital cardiac arrest patients undergoing defibrillation received an escalating higher-energy regimen beginning with 200 J, proceeding to 300 J for the second shock and 360 J for all remaining shocks

Procedure: Escalating higher-energy defibrillation

Interventions

Fixed lower-energy defibrillationPROCEDURE

Every shock administered at 150 J

Fixed lower-energy
Escalating higher-energy defibrillationPROCEDURE

First shock administered at 200 J, second shock at 300 J, all subsequent shocks at 360 J

Escalating higher-Energy

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Witnessed cardiac arrest out-of-hospital requiring defibrillation and given by first responder using an automated external defibrillator

You may not qualify if:

  • Terminal illness or do-not-resuscitate (DNR) status
  • No cardiopulmonary resuscitation (CPR) x 10 minutes
  • Acute trauma
  • Exsanguination
  • Cardiac arrest experienced while in hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related 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-hospital cardiac arrest. Circulation. 2007 Mar 27;115(12):1511-7. doi: 10.1161/CIRCULATIONAHA.106.648204. Epub 2007 Mar 12.

    PMID: 17353443RESULT

MeSH Terms

Conditions

Heart ArrestVentricular Fibrillation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

None applicable.

Results Point of Contact

Title
Dr. Ian G. Stiell, Senior Scientist
Organization
Ottawa Hospital Research Institute
istiell@ohri.ca
613-798-5555

Study Officials

  • Ian Stiell, MD

    OHRI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

March 1, 2001

Primary Completion

September 1, 2005

Study Completion

July 1, 2006

Last Updated

April 25, 2025

Results First Posted

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)