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Epinephrine Dose: Optimal Versus Standard Evaluation Trial (EpiDOSE)

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ClinicalTrials.gov Identifier: NCT03826524
Recruitment Status : Not yet recruiting
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Pfizer
Information provided by (Responsible Party):
Paul Dorian, St. Michael's Hospital, Toronto

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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest, Out-Of-Hospital Sudden Cardiac Arrest Ventricular Fibrillation Ventricular Tachycardia-Pulseless Drug: Epinephrine Phase 4

Detailed Description:

This study is designed as a prospective, multicentre, double-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 + 6mg placebo saline) or a standard cumulative dose of epinephrine (standard dose epinephrine, up to 8mg total) in a 1:1 fashion.

Eligible OHCA patients will be treated by emergency medical service (EMS) providers who will initiate cardiopulmonary resuscitation (CPR) and the delivery of defibrillation shocks per EMS treatment protocols. After one defibrillation and when feasible, EMS providers will establish peripheral intravenous (IV) access, and patients will be randomly allocated to 1 of the 2 study arms. Subsequent study drug doses will be administered every 3-5 minutes, based on current guidelines and paramedic protocols, during resuscitation 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 interviews. Telephone interviews with survivors are planned for 12+/-3 months post-arrest.

This RCT will evaluate a fundamental change in the treatment of OHCA. The investigators hypothesize that a low cumulative dose epinephrine will improve patient survival to hospital discharge compared to a standard cumulative dose epinephrine.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3790 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CanROC Epinephrine Dose: Optimal Versus Standard Evaluation Trial (CanROC EpiDOSE Trial)
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : January 2025


Arm Intervention/treatment
Active Comparator: Low Dose Epinephrine
Epinephrine up to 2mg total
Drug: Epinephrine
Epinephrine 1mg 1:10000 (10cc) per dose
Other Name: Adrenaline

Active Comparator: Standard Dose Epinephrine
Epinephrine up to 8mg total
Drug: Epinephrine
Epinephrine 1mg 1:10000 (10cc) per dose
Other Name: Adrenaline




Primary Outcome Measures :
  1. Survival to hospital discharge [ Time Frame: Through study completion (up to 5 years) ]
    Individuals discharged alive from hospital


Secondary Outcome Measures :
  1. Return of spontaneous circulation in out-of-hospital setting [ Time Frame: Through study completion (up to 5 years) ]
    Return of spontaneous circulation in the field

  2. Survival to emergency department arrival [ Time Frame: Through study completion (up to 5 years) ]
    Individuals alive upon arrival to a hospital emergency department

  3. Survival to admission with death prior to discharge [ Time Frame: Through study completion (up to 5 years) ]
    Individuals alive upon hospital admission who die in-hospital before being discharged

  4. Survival to discharge outside of a long-term healthcare facility e.g. nursing home [ Time Frame: Through study completion (up to 5 years) ]
    Individuals discharged alive from hospital to a care facility

  5. Modified Rankin Scale (mRS) score [ 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)

  6. Health Utility Index-3 (HUI-3) score [ 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)

  7. Hospital Anxiety and Depression Scale score [ Time Frame: 12+/-3 months ]
    Assessment of quality of life, scores range from 0 to 21 where higher scores indicate more anxiety/depression

  8. Length of stay in hospital [ Time Frame: Through study completion (up to 5 years) ]
    Length of time an individual remained in-hospital (length in days)

  9. Length of stay in critical care unit [ Time Frame: Through study completion (up to 5 years) ]
    Length of time an individual remained in a crucial care unit (length in days)

  10. Survival post-arrest [ Time Frame: Up to 5 years ]
    Survival following hospital discharge, up to 5 years

  11. Recurrent cardiac arrest(s) [ Time Frame: Up to 5 years ]
    Number of cardiac arrests following the index arrest

  12. ICD implant post-arrest [ Time Frame: Up to 5 years ]
    Whether an implantable cardioverter defibrillator was implanted post-arrest

  13. Cardiovascular re-hospitalization(s) [ Time Frame: Up to 5 years ]
    Number of cardiovascular re-hospitalizations

  14. All-cause re-hospitalizations(s) [ Time Frame: Up to 5 years ]
    Number of re-hospitalizations for any reason



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Out-of-hospital cardiac arrest treated by paramedics
  2. Initial EMS recorded cardiac rhythm of VF or pulseless VT, or EMS AED shock
  3. Established intravenous vascular access

Exclusion Criteria:

  1. Known or apparent age <18 years
  2. Initial recorded cardiac rhythm of pulseless electrical activity (PEA) or asystole
  3. 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.)
  4. Prior receipt of open-label intravenous or intramuscular epinephrine during resuscitation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826524


Contacts
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Contact: Theresa Aves, MSc 416-864-6060 ext 6787 avest@smh.ca

Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Institutes of Health Research (CIHR)
Pfizer
Investigators
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Principal Investigator: Paul Dorian, MD, MSc St. Michael's Hospital, Toronto
Principal Investigator: Steve Lin, MD, MSc St. Michael's Hospital, Toronto

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Responsible Party: Paul Dorian, Principal Investigator, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03826524     History of Changes
Other Study ID Numbers: EpiDOSE Protocol Version 1.0
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul Dorian, St. Michael's Hospital, Toronto:
out-of-hospital cardiac arrest
sudden cardiac arrest
epinephrine
randomized controlled trial
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Heart Arrest
Ventricular Fibrillation
Death, Sudden, Cardiac
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes
Death, Sudden
Death
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics