Ventricular Fibrillation Clinical Trial
— EpiDOSEOfficial title:
CanROC Epinephrine Dose: Optimal Versus Standard Evaluation Trial (CanROC EpiDOSE Trial)
The objective of this randomized controlled trial is to evaluate the effectiveness of a low cumulative dose of epinephrine compared to a standard cumulative dose of epinephrine during resuscitation from ventricular fibrillation (VF) or ventricular tachycardia (VT) in adult out-of-hospital cardiac arrest (OHCA) patients.
Status | Recruiting |
Enrollment | 3790 |
Est. completion date | June 2028 |
Est. primary completion date | December 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Out-of-hospital cardiac arrest treated by paramedics - Initial recorded cardiac rhythm of VF or pulseless VT, or, AED shock on first analysis administered or witnessed by EMS (paramedic or fire) - Established intravenous vascular access Exclusion Criteria: - Known or apparent age <18 years - Initial recorded cardiac rhythm of pulseless electrical activity or asystole - Cardiac arrest due to an obvious non-cardiac primary cause (e.g. blunt or penetrating trauma, exsanguination, burns, drug overdose, drowning, anaphylaxis, sudden asphyxiation, etc.) - Prisoners or persons in police custody - Known allergy or sensitivity to epinephrine - Prior receipt of non-study kit intravenous, intraosseous, or intramuscular epinephrine during resuscitation |
Country | Name | City | State |
---|---|---|---|
Canada | Halton Region Paramedic Services | Halton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Unity Health Toronto | Canadian Institutes of Health Research (CIHR), Pfizer |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival to hospital discharge | Individuals discharged alive from hospital | Through study completion (up to 5 years) | |
Secondary | Return of spontaneous circulation in out-of-hospital setting | Return of spontaneous circulation in the field | Through study completion (up to 5 years) | |
Secondary | Survival to emergency department arrival | Individuals alive upon arrival to a hospital emergency department | Through study completion (up to 5 years) | |
Secondary | Survival to admission with death prior to discharge | Individuals alive upon hospital admission who die in-hospital before being discharged | Through study completion (up to 5 years) | |
Secondary | Survival to discharge outside of a long-term healthcare facility e.g. nursing home | Individuals discharged alive from hospital to a care facility | Through study completion (up to 5 years) | |
Secondary | Modified Rankin Scale (mRS) score | Assessment of neurological function, scores range from 0 to 6 where higher scores indicate worse neurological function (0=no symptoms, 6=dead) | 12+/-3 months | |
Secondary | Health Utility Index-3 (HUI-3) score | Assessment of quality of life, scores range from -0.36 to 1 where higher scores indicate better quality life (negative scores=a state worse than being dead, 0=dead, 1=perfect health) | 12+/-3 months | |
Secondary | Hospital Anxiety and Depression Scale score | Assessment of quality of life, scores range from 0 to 21 where higher scores indicate more anxiety/depression | 12+/-3 months | |
Secondary | Length of stay in hospital | Length of time an individual remained in-hospital (length in days) | Through study completion (up to 5 years) | |
Secondary | Length of stay in critical care unit | Length of time an individual remained in a crucial care unit (length in days) | Through study completion (up to 5 years) | |
Secondary | Survival post-arrest | Survival following hospital discharge, up to 5 years | Up to 5 years | |
Secondary | Recurrent cardiac arrest(s) | Number of cardiac arrests following the index arrest | Up to 5 years | |
Secondary | ICD implant post-arrest | Whether an implantable cardioverter defibrillator was implanted post-arrest | Up to 5 years | |
Secondary | Cardiovascular re-hospitalization(s) | Number of cardiovascular re-hospitalizations | Up to 5 years | |
Secondary | All-cause re-hospitalizations(s) | Number of re-hospitalizations for any reason | Up to 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Completed |
NCT05791032 -
Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study
|
N/A | |
Completed |
NCT04011631 -
Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System.
|
N/A | |
Active, not recruiting |
NCT03700125 -
Pre-hospital ECMO in Advanced Resuscitation in Patients With Refractory Cardiac Arrest. ( SUB30 )
|
N/A | |
Not yet recruiting |
NCT05325385 -
Ventricular Fibrillation Following Out-of-hospital Cardiac Arrest
|
||
Completed |
NCT00241800 -
Medications and the Risk of Sudden Cardiac Death
|
N/A | |
Completed |
NCT00139542 -
AED Use in Out-of-Hospital Cardiac Arrest: A New Algorithm Named "One Shock Per Minute"
|
Phase 3 | |
Completed |
NCT00119847 -
Electrophysiological Effects of Late PCI After MI
|
N/A | |
Completed |
NCT00004560 -
Public Access Defibrillation (PAD) Community Trial
|
Phase 3 | |
Completed |
NCT00000531 -
Antiarrhythmics Versus Implantable Defibrillators (AVID)
|
Phase 3 | |
Completed |
NCT00000502 -
Evaluation of SC-V Versus Conventional CPR
|
Phase 3 | |
Completed |
NCT00000492 -
Beta-Blocker Heart Attack Trial (BHAT)
|
Phase 3 | |
Completed |
NCT04080986 -
DOuble SEquential External Defibrillation for Refractory VF
|
N/A | |
Completed |
NCT01789554 -
The Use of Mobile Phones in Out of Hospital Cardiac Arrest to Increase Bystander CPR
|
N/A | |
Completed |
NCT01940081 -
The Leiden Nonischemic Cardiomyopathy Study
|
||
Completed |
NCT01089634 -
Left Ventricular Capture Management Study
|
||
Completed |
NCT00382928 -
Automatic External Defibrillation Monitoring in Cardiac Arrest
|
Phase 1 | |
Completed |
NCT01161589 -
First Arrhythmia Collection of Transvenous and Simultaneous Subcutaneous Implantable Defibrillator Data
|
N/A | |
Terminated |
NCT00776087 -
European Health Economic Trial on Home Monitoring in ICD and CRT-D Patients (EuroEco)
|
N/A | |
Recruiting |
NCT04576130 -
A Danish ICD-study in Patients With Coronary Artery Disease Resuscitated From Ventricular Fibrillation
|
N/A |