Trial Outcomes & Findings for Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy (NCT NCT00212992)
NCT ID: NCT00212992
Last Updated: 2025-04-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
221 participants
Primary outcome timeframe
Termination of defibrillation
Results posted on
2025-04-25
Participant Flow
Participant milestones
| Measure |
Fixed Lower-energy
Out-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks
|
Escalating Higher-energy
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
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
107
|
|
Overall Study
COMPLETED
|
114
|
107
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Fixed Lower-energy
n=114 Participants
Out-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks
|
Escalating Higher-energy
n=107 Participants
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
|
Total
n=221 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.0 Years
STANDARD_DEVIATION 14.2 • n=114 Participants
|
66.1 Years
STANDARD_DEVIATION 14.5 • n=107 Participants
|
66.0 Years
STANDARD_DEVIATION 14.4 • n=221 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=114 Participants
|
18 Participants
n=107 Participants
|
44 Participants
n=221 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=114 Participants
|
89 Participants
n=107 Participants
|
177 Participants
n=221 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
114 participants
n=114 Participants
|
107 participants
n=107 Participants
|
221 participants
n=221 Participants
|
|
Initial Rhythm
VT/VF
|
103 Participants
n=114 Participants
|
103 Participants
n=107 Participants
|
206 Participants
n=221 Participants
|
|
Initial Rhythm
Asystole
|
6 Participants
n=114 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=221 Participants
|
|
Initial Rhythm
Pulseless electrical activity
|
5 Participants
n=114 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=221 Participants
|
PRIMARY outcome
Timeframe: Termination of defibrillationOutcome measures
| Measure |
Fixed Lower-energy
n=114 Participants
Out-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks
|
Escalating Higher-energy
n=107 Participants
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
|
|---|---|---|
|
Successful Conversion to an Organized Heart Rhythm
|
28 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Fixed Lower-energy
n=114 Participants
Out-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks
|
Escalating Higher-energy
n=107 Participants
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
|
|---|---|---|
|
Survival to Hospital Discharge
|
19 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: One hour from termination of defibrillationOutcome measures
| Measure |
Fixed Lower-energy
n=114 Participants
Out-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks
|
Escalating Higher-energy
n=107 Participants
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
|
|---|---|---|
|
Resuscitation for Survival to One Hour
|
54 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Patients who survived to hospital discharge
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.
Outcome measures
| Measure |
Fixed Lower-energy
n=19 Participants
Out-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks
|
Escalating Higher-energy
n=17 Participants
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
|
|---|---|---|
|
Neurologic Function
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: Termination of defibrillationOutcome measures
| Measure |
Fixed Lower-energy
n=114 Participants
Out-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks
|
Escalating Higher-energy
n=107 Participants
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
|
|---|---|---|
|
Return of Spontaneous Circulation
|
58 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
Fixed Lower-energy
n=114 Participants
Out-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks
|
Escalating Higher-energy
n=107 Participants
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
|
|---|---|---|
|
Survival to 24 Hours
|
37 Participants
|
38 Participants
|
Adverse Events
Fixed Lower-energy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Escalating Higher-energy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ian G. Stiell, Senior Scientist
Ottawa Hospital Research Institute
Phone: 613-798-5555
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place