Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-02 @ 3:08 AM
Study NCT ID:
NCT00212992
Status:
COMPLETED
Last Update Posted:
2025-04-25
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy
Sponsor:
Ottawa Hospital Research Institute
Organization:
Study Overview
Official Title:
A Pilot Randomized Controlled Trial to Compare Fixed Versus Escalating Energy Regimens for Biphasic Waveform Defibrillation
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: