Epinephrine
DrugEpinephrine 1mg 1:10000 (10cc) per dose
Other names: Adrenaline
NCT Number: NCT03826524
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
British Columbia Emergency Health Services (BCEHS), Victoria, British Columbia, Canada
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 [email protected] for further information.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Epinephrine 1mg 1:10000 (10cc) per dose
Other names: Adrenaline
Time frame: Through study completion (up to 5 years)
Individuals discharged alive from hospital
Time frame: Through study completion (up to 5 years)
Return of spontaneous circulation in the field
Time frame: Through study completion (up to 5 years)
Individuals alive upon arrival to a hospital emergency department
Time frame: Through study completion (up to 5 years)
Individuals alive upon hospital admission who die in-hospital before being discharged
Time frame: Through study completion (up to 5 years)
Individuals discharged alive from hospital to a care facility
Time frame: 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)
Time frame: 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)
Time frame: 12+/-3 months
Assessment of quality of life, scores range from 0 to 21 where higher scores indicate more anxiety/depression
Time frame: Through study completion (up to 5 years)
Length of time an individual remained in-hospital (length in days)
Time frame: Through study completion (up to 5 years)
Length of time an individual remained in a crucial care unit (length in days)
Time frame: Up to 5 years
Survival following hospital discharge, up to 5 years
Time frame: Up to 5 years
Number of cardiac arrests following the index arrest
Time frame: Up to 5 years
Whether an implantable cardioverter defibrillator was implanted post-arrest
Time frame: Up to 5 years
Number of cardiovascular re-hospitalizations
Time frame: Up to 5 years
Number of re-hospitalizations for any reason
Contact information is provided by the study sponsor or research team.
Unity Health Toronto
Other
CanROC Epinephrine Dose: Optimal Versus Standard Evaluation Trial (CanROC EpiDOSE Trial)
Acronym: EpiDOSE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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