Epinephrine Dose: Optimal Versus Standard Evaluation Trial
- Conditions
- Sudden Cardiac ArrestCardiac Arrest, Out-Of-HospitalVentricular FibrillationVentricular Tachycardia-Pulseless
- Interventions
- Registration Number
- NCT03826524
- Lead Sponsor
- Unity Health Toronto
- Brief Summary
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.
- Detailed Description
This study is designed as a prospective, multicentre, single-blinded randomized controlled trial (RCT) where eligible OHCA patients are randomized to receive a low cumulative dose of epinephrine (low dose epinephrine, up to 2mg total) or a standard cumulative dose of epinephrine (standard dose epinephrine, up to 6mg total) in a 1:1 fashion.
Eligible OHCA patients will be treated by paramedics who will initiate cardiopulmonary resuscitation (CPR) and the delivery of defibrillation shocks per paramedic agencies' treatment protocols. After one defibrillation and when feasible, paramedics will establish peripheral intravenous (IV) access, and patients will be randomly allocated to either the low dose or standard dose treatment arm. Epinephrine doses (according to treatment assignment) will be administered every 3-5 minutes, based on current guidelines and paramedic protocols, until the first return of spontaneous circulation (ROSC) is achieved or if resuscitation has been terminated by the base hospital physician. Other medications (e.g. antiarrhythmics, magnesium, beta blockers) and interventions (e.g. intubation) may be interposed as required. Follow-up will take place using a combination of administrative databases (e.g. the Discharge Abstract Database and the National Ambulatory Care Reporting System) and telephone interviews.
This RCT will evaluate a fundamental change in the treatment of OHCA. The investigators hypothesize that a low cumulative dose of epinephrine will improve patient survival to hospital discharge compared to a standard cumulative dose of epinephrine. Please feel free to contact epidose@unityhealth.to for further information.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3790
- 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
- Known or apparent age <18 years
- Initial recorded cardiac rhythm of VF or pulseless VT, or, AED shock on first analysis administered or confirmed by paramedics
- 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.)
- Administration of intramuscular, endotracheal tube, or intraosseous epinephrine
- Prisoners or persons in police custody
- Known allergy or sensitivity to epinephrine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low Dose Epinephrine Epinephrine Epinephrine up to 2mg total Standard Dose Epinephrine Epinephrine Epinephrine up to 6mg total
- Primary Outcome Measures
Name Time Method Survival to hospital discharge Through study completion (up to 5 years) Individuals discharged alive from hospital
- Secondary Outcome Measures
Name Time Method Survival post-arrest Up to 5 years Survival following hospital discharge, up to 5 years
ICD implant post-arrest Up to 5 years Whether an implantable cardioverter defibrillator was implanted post-arrest
Survival to admission with death prior to discharge Through study completion (up to 5 years) Individuals alive upon hospital admission who die in-hospital before being discharged
Recurrent cardiac arrest(s) Up to 5 years Number of cardiac arrests following the index arrest
All-cause re-hospitalizations(s) Up to 5 years Number of re-hospitalizations for any reason
Return of spontaneous circulation in out-of-hospital setting Through study completion (up to 5 years) Return of spontaneous circulation in the field
Survival to emergency department arrival Through study completion (up to 5 years) Individuals alive upon arrival to a hospital emergency department
Survival to discharge outside of a long-term healthcare facility e.g. nursing home Through study completion (up to 5 years) Individuals discharged alive from hospital to a care facility
Modified Rankin Scale (mRS) score 12+/-3 months Assessment of neurological function, scores range from 0 to 6 where higher scores indicate worse neurological function (0=no symptoms, 6=dead)
Health Utility Index-3 (HUI-3) score 12+/-3 months 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)
Hospital Anxiety and Depression Scale score 12+/-3 months Assessment of quality of life, scores range from 0 to 21 where higher scores indicate more anxiety/depression
Length of stay in hospital Through study completion (up to 5 years) Length of time an individual remained in-hospital (length in days)
Length of stay in critical care unit Through study completion (up to 5 years) Length of time an individual remained in a crucial care unit (length in days)
Cardiovascular re-hospitalization(s) Up to 5 years Number of cardiovascular re-hospitalizations
Trial Locations
- Locations (3)
British Columbia Emergency Health Services (BCEHS)
🇨🇦Victoria, British Columbia, Canada
Ottawa Paramedic Services
🇨🇦Ottawa, Ontario, Canada
Halton Region Paramedic Services
🇨🇦Halton, Ontario, Canada