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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Epinephrine | Active Comparator | Epinephrine up to 2mg total |
|
| Standard Dose Epinephrine | Active Comparator | Epinephrine up to 6mg total |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epinephrine | Drug | Epinephrine 1mg 1:10000 (10cc) per dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival to hospital discharge | Individuals discharged alive from hospital | Through study completion (up to 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Return of spontaneous circulation in out-of-hospital setting | Return of spontaneous circulation in the field | Through study completion (up to 5 years) |
| Survival to emergency department arrival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Theresa Aves, MSc | Contact | 416-864-6060 | 46787 | theresa.aves@unityhealth.to |
| Name | Affiliation | Role |
|---|---|---|
| Paul Dorian, MD, MSc | Unity Health Toronto | Principal Investigator |
| Steve Lin, MD, MSc | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| British Columbia Emergency Health Services (BCEHS) | Recruiting | Victoria | British Columbia | V8W 9P1 | Canada |
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| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| D016757 | Death, Sudden, Cardiac |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Individuals alive upon arrival to a hospital emergency department
| Through study completion (up to 5 years) |
| Survival to admission with death prior to discharge | Individuals alive upon hospital admission who die in-hospital before being discharged | Through study completion (up to 5 years) |
| Survival to discharge outside of a long-term healthcare facility e.g. nursing home | Individuals discharged alive from hospital to a care facility | Through study completion (up to 5 years) |
| Modified Rankin Scale (mRS) score | Assessment of neurological function, scores range from 0 to 6 where higher scores indicate worse neurological function (0=no symptoms, 6=dead) | 12+/-3 months |
| Health Utility Index-3 (HUI-3) score | 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) | 12+/-3 months |
| Hospital Anxiety and Depression Scale score | Assessment of quality of life, scores range from 0 to 21 where higher scores indicate more anxiety/depression | 12+/-3 months |
| Length of stay in hospital | Length of time an individual remained in-hospital (length in days) | Through study completion (up to 5 years) |
| Length of stay in critical care unit | Length of time an individual remained in a crucial care unit (length in days) | Through study completion (up to 5 years) |
| Survival post-arrest | Survival following hospital discharge, up to 5 years | Up to 5 years |
| Recurrent cardiac arrest(s) | Number of cardiac arrests following the index arrest | Up to 5 years |
| ICD implant post-arrest | Whether an implantable cardioverter defibrillator was implanted post-arrest | Up to 5 years |
| Cardiovascular re-hospitalization(s) | Number of cardiovascular re-hospitalizations | Up to 5 years |
| All-cause re-hospitalizations(s) | Number of re-hospitalizations for any reason | Up to 5 years |
| Peel Regional Paramedic Services | Recruiting | Brampton | Ontario | L6T 4B9 | Canada |
|
| Middlesex-London Paramedic Service | Recruiting | London | Ontario | N6E 1R4 | Canada |
|
| Halton Region Paramedic Services | Recruiting | Oakville | Ontario | L6M 3L1 | Canada |
|
| Ottawa Paramedic Services | Recruiting | Ottawa | Ontario | K1H 1E2 | Canada |
|
| Superior North Emergency Medical Services | Recruiting | Thunder Bay | Ontario | P7B 4X6 | Canada |
|
| Essex-Windsor Emergency Health Services | Recruiting | Windsor | Ontario | N9A 1N6 | Canada |
|
| Medavie Health Services West | Recruiting | Saskatoon | Saskatchewan | S7J 4M2 | Canada |
|
| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |