CanROC Epinephrine Dose: Optimal Versus Standard Evaluation Trial (CanROC EpiDOSE Trial)

EpiDOSE Protocol Version 2.2

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.

2023-05-24

2027-12-01

2028-06-01

Recruiting

Early phase I

3790

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 3790, 'type': 'ESTIMATED'}}

2023-06-07