Epinephrine Dose: Optimal Versus Standard Evaluation Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Epinephrine.
- Who it may be relevant to
- Registry conditions: Cardiac Arrest, Out-Of-Hospital, Sudden Cardiac Arrest, Ventricular Fibrillation, Ventricular Tachycardia-Pulseless. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
CanROC Epinephrine Dose: Optimal Versus Standard Evaluation Trial (CanROC EpiDOSE Trial)
Overview
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.
Interventions
- Drug Epinephrine
Epinephrine 1mg 1:10000 (10cc) per dose
Primary outcome measures
- Survival to hospital discharge [Time frame: Through study completion (up to 5 years)]
Secondary outcome measures (12)
- Return of spontaneous circulation in out-of-hospital setting [Time frame: Through study completion (up to 5 years)]
- Survival to emergency department arrival [Time frame: Through study completion (up to 5 years)]
- Survival to admission with death prior to discharge [Time frame: Through study completion (up to 5 years)]
- Survival to discharge outside of a long-term healthcare facility e.g. nursing home [Time frame: Through study completion (up to 5 years)]
- Modified Rankin Scale (mRS) score [Time frame: 12+/-3 months]
- Health Utility Index-3 (HUI-3) score [Time frame: 12+/-3 months]
- Hospital Anxiety and Depression Scale score [Time frame: 12+/-3 months]
- Length of stay in hospital [Time frame: Through study completion (up to 5 years)]
- Length of stay in critical care unit [Time frame: Through study completion (up to 5 years)]
- Survival post-arrest [Time frame: Up to 5 years]
- Recurrent cardiac arrest(s) [Time frame: Up to 5 years]
- ICD implant post-arrest [Time frame: Up to 5 years]
Eligibility criteria
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Canada · 8 centers
- British Columbia Emergency Health Services (BCEHS) — Victoria
- Peel Regional Paramedic Services — Brampton
- Middlesex-London Paramedic Service — London
- Halton Region Paramedic Services — Oakville
- Ottawa Paramedic Services — Ottawa
- Superior North Emergency Medical Services — Thunder Bay
- Essex-Windsor Emergency Health Services — Windsor
- Medavie Health Services West — Saskatoon
Identifiers
NCT: NCT03826524 · EpiDOSE Protocol Version 3.0