Cardiac Arrest, Out-Of-Hospital, Sudden Cardiac Arrest, Ventricular Fibrillation, Ventricular Tachycardia-Pulseless
Conditions
Keywords
out-of-hospital cardiac arrest, sudden cardiac arrest, epinephrine, randomized controlled trial
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.
Interventions
DRUGEpinephrine
Epinephrine 1mg 1:10000 (10cc) per dose
Sponsors
Canadian Institutes of Health Research (CIHR)
Pfizer
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival to hospital discharge | Through study completion (up to 5 years) | Individuals discharged alive from hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival to emergency department arrival | Through study completion (up to 5 years) | Individuals alive upon arrival to a hospital emergency department |
| 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 |
| 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 |
| Return of spontaneous circulation in out-of-hospital setting | Through study completion (up to 5 years) | Return of spontaneous circulation in the field |
| 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) |
| Survival post-arrest | Up to 5 years | Survival following hospital discharge, up to 5 years |
| Recurrent cardiac arrest(s) | Up to 5 years | Number of cardiac arrests following the index arrest |
| ICD implant post-arrest | Up to 5 years | Whether an implantable cardioverter defibrillator was implanted post-arrest |
| Cardiovascular re-hospitalization(s) | Up to 5 years | Number of cardiovascular re-hospitalizations |
| All-cause re-hospitalizations(s) | Up to 5 years | Number of re-hospitalizations for any reason |
| Length of stay in hospital | Through study completion (up to 5 years) | Length of time an individual remained in-hospital (length in days) |
Countries
Canada
Contacts
Primary ContactTheresa Aves, MSc
Outcome results
None listed