Cardiac ArrestPhase 3NCT00212992
Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy
A Phase 3 study testing Fixed lower-energy defibrillation and Escalating higher-energy defibrillation in people with Cardiac Arrest, run by Ottawa Hospital Research Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Fixed lower-energy defibrillation and Escalating higher-energy defibrillation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2001to Jul 2006
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Witnessed cardiac arrest out-of-hospital requiring defibrillation and given by first responder using an automated external defibrillator
Who cannot join
- Terminal illness or do-not-resuscitate (DNR) status
- No cardiopulmonary resuscitation (CPR) x 10 minutes
- Acute trauma
- Exsanguination
- Cardiac arrest experienced while in hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Controlled Trial to Compare Fixed Versus Escalating Energy Regimens for Biphasic Waveform Defibrillation
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.
Read the 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.
- Conditions
- Cardiac Arrest
- Being tested
- Fixed lower-energy defibrillation, Escalating higher-energy defibrillation
- Keywords
- defibrillation, ventricular fibrillation, heart arrest
- Medical subject headings
- Heart Arrest, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed lower-energy defibrillationProcedure or surgery
Every shock administered at 150 J
Escalating higher-energy defibrillationProcedure or surgery
First shock administered at 200 J, second shock at 300 J, all subsequent shocks at 360 J
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Escalating higher-energy defibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Conversion to an Organized Heart Rhythm
Measured: Termination of defibrillation
Secondary outcomes (5)
Survival to Hospital Discharge
Measured: 30 days
Resuscitation for Survival to One Hour
Measured: One hour from termination of defibrillation
Neurologic Function
The Cerebral Performance Category Score (CPC) is a five-point scale used to assess neurological outcomes after cardiac arrest. The best score, 1, indicates good cerebral performance. The worst score, 5, represents brain death.
Measured: 30 days
Return of Spontaneous Circulation
Measured: Termination of defibrillation
Survival to 24 Hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMar 2001
- Primary completionSep 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Stiell, MD, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212992
- Sponsor's protocol ID
- 2001266-01H
- Status last verified
- Apr 2025
- First submitted
- 13 Sep 2005
- Last updated
- 25 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17353443
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial to Compare Fixed Versus Escalating Energy Regimens for Biphasic Waveform Defibrillation
- ClinicalTrials.gov ID
- NCT00212992
- Acronym / sponsor ID
- 2001266-01H
- Conditions
- Cardiac Arrest
- Keywords
- defibrillation, ventricular fibrillation, heart arrest
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Mar 2001 (actual)
- Primary completion
- Sep 2005 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 25 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed lower-energy | Active comparator | Procedure: Fixed lower-energy defibrillationOut-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks |
| Escalating higher-Energy | Active comparator | Procedure: Escalating higher-energy defibrillationOut-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 |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Witnessed cardiac arrest out-of-hospital requiring defibrillation and given by first responder using an automated external defibrillator
Key exclusion criteria (5 listed)
- Terminal illness or do-not-resuscitate (DNR) status
- No cardiopulmonary resuscitation (CPR) x 10 minutes
- Acute trauma
- Exsanguination
- Cardiac arrest experienced while in hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed lower-energy defibrillationEvery shock administered at 150 J | Procedure or surgery | Fixed lower-energy |
| Escalating higher-energy defibrillationFirst shock administered at 200 J, second shock at 300 J, all subsequent shocks at 360 J | Procedure or surgery | Escalating higher-Energy |
Primary outcome
Successful Conversion to an Organized Heart Rhythm
Time frame: Termination of defibrillation
5 secondary outcomes
Survival to Hospital Discharge
Time frame: 30 days
Resuscitation for Survival to One Hour
Time frame: One hour from termination of defibrillation
Neurologic Function
Time frame: 30 days
Return of Spontaneous Circulation
Time frame: Termination of defibrillation
Survival to 24 Hours
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17353443Stiell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Stiell, MD principal investigator
OHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fixed lower-energy defibrillation and Escalating higher-energy defibrillation in people with Cardiac Arrest, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Conversion to an Organized Heart Rhythm (time frame: Termination of defibrillation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00212992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.