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Trial record 1 of 1 for:    NCT03826524
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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 : May 15, 2020
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Pfizer
Information provided by (Responsible Party):
Paul Dorian, St. Michael's Hospital, Toronto

Tracking Information
First Submitted Date  ICMJE November 7, 2018
First Posted Date  ICMJE February 1, 2019
Last Update Posted Date May 15, 2020
Estimated Study Start Date  ICMJE October 2020
Estimated Primary Completion Date November 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
Survival to hospital discharge [ Time Frame: Through study completion (up to 5 years) ]
Individuals discharged alive from hospital
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • 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
  • Survival to emergency department arrival [ Time Frame: Through study completion (up to 5 years) ]
    Individuals alive upon arrival to a hospital emergency department
  • 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
  • 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
  • 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)
  • 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)
  • 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
  • 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)
  • 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)
  • Survival post-arrest [ Time Frame: Up to 5 years ]
    Survival following hospital discharge, up to 5 years
  • Recurrent cardiac arrest(s) [ Time Frame: Up to 5 years ]
    Number of cardiac arrests following the index arrest
  • ICD implant post-arrest [ Time Frame: Up to 5 years ]
    Whether an implantable cardioverter defibrillator was implanted post-arrest
  • Cardiovascular re-hospitalization(s) [ Time Frame: Up to 5 years ]
    Number of cardiovascular re-hospitalizations
  • All-cause re-hospitalizations(s) [ Time Frame: Up to 5 years ]
    Number of re-hospitalizations for any reason
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epinephrine Dose: Optimal Versus Standard Evaluation Trial
Official Title  ICMJE CanROC Epinephrine Dose: Optimal Versus Standard Evaluation Trial (CanROC EpiDOSE 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 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiac Arrest, Out-Of-Hospital
  • Sudden Cardiac Arrest
  • Ventricular Fibrillation
  • Ventricular Tachycardia-Pulseless
Intervention  ICMJE Drug: Epinephrine
Epinephrine 1mg 1:10000 (10cc) per dose
Other Name: Adrenaline
Study Arms  ICMJE
  • Active Comparator: Low Dose Epinephrine
    Epinephrine up to 2mg total
    Intervention: Drug: Epinephrine
  • Active Comparator: Standard Dose Epinephrine
    Epinephrine up to 8mg total
    Intervention: Drug: Epinephrine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2019)
3790
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2026
Estimated Primary Completion Date November 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Theresa Aves, MSc 416-864-6060 ext 6787 theresa.aves@unityhealth.to
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03826524
Other Study ID Numbers  ICMJE EpiDOSE Protocol Version 2.0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Paul Dorian, St. Michael's Hospital, Toronto
Study Sponsor  ICMJE St. Michael's Hospital, Toronto
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • Pfizer
Investigators  ICMJE
Principal Investigator: Paul Dorian, MD, MSc St. Michael's Hospital, Toronto
Principal Investigator: Steve Lin, MD, MSc St. Michael's Hospital, Toronto
PRS Account St. Michael's Hospital, Toronto
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP