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Adrenalindose: Optimal Versus Standard Evalueringsforsøk (EpiDOSE)

28. september 2026 oppdatert av: Unity Health Toronto

CanROC epinefrindose: Optimal Versus Standard Evaluation Trial (CanROC EpiDOSE Trial)

The objective of this randomized controlled trial is to evaluate whether a low cumulative dose of epinephrine ("low dose") is non-inferior to a standard cumulative dose of epinephrine ("standard dose") with respect to survival to hospital discharge among adults undergoing resuscitation for OHCA due to ventricular fibrillation (VF) or pulseless ventricular tachycardia (pVT).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

1250

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8W 9P1
        • Rekruttering
        • British Columbia Emergency Health Services (BCEHS)
        • Hovedetterforsker:
          • Brian Grunau, MD
        • Ta kontakt med:
    • Ontario
      • Brampton, Ontario, Canada, L6T 4B9
        • Rekruttering
        • Peel Regional Paramedic Services
        • Hovedetterforsker:
          • Sheldon Cheskes, MD
        • Ta kontakt med:
      • London, Ontario, Canada, N6E 1R4
        • Rekruttering
        • Middlesex-London Paramedic Service
        • Hovedetterforsker:
          • Christian Vaillancourt, MD
        • Ta kontakt med:
        • Underetterforsker:
          • Matthew Davis, MD
      • Oakville, Ontario, Canada, L6M 3L1
        • Rekruttering
        • Halton Region Paramedic Services
        • Hovedetterforsker:
          • Sheldon Cheskes, MD
        • Ta kontakt med:
      • Ottawa, Ontario, Canada, K1H 1E2
        • Rekruttering
        • Ottawa Paramedic Services
        • Hovedetterforsker:
          • Christian Vaillancourt, MD
        • Ta kontakt med:
      • Thunder Bay, Ontario, Canada, P7B 4X6
        • Rekruttering
        • Superior North Emergency Medical Services
        • Hovedetterforsker:
          • Christian Vaillancourt, MD
        • Ta kontakt med:
        • Underetterforsker:
          • David Savage, MD
      • Waterloo, Ontario, Canada, N2G 4J3
        • Rekruttering
        • Region of Waterloo Paramedic Services
        • Ta kontakt med:
        • Hovedetterforsker:
          • Paul Miller, MD
      • Windsor, Ontario, Canada, N9A 1N6
        • Rekruttering
        • Essex-Windsor Emergency Health Services
        • Hovedetterforsker:
          • Christian Vaillancourt, MD
        • Ta kontakt med:
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7J 4M2
        • Rekruttering
        • Medavie Health Services West
        • Ta kontakt med:
        • Hovedetterforsker:
          • Andrew Leach, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Out-of-hospital cardiac arrest treated by paramedics AND
  • Initial recorded cardiac rhythm of VF or pulseless VT, or, AED shock on first analysis administered or confirmed by paramedics or fire services, AND
  • 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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Low Dose Epinephrine

Epinephrine up to 2mg total
Legemiddel: Epinephrine

Epinephrine 1mg 1:10000 (10cc) per dose

Andre navn:
  • Adrenalin
Aktiv komparator: Standard Dose Epinephrine

Epinephrine up to 6mg total
Legemiddel: Epinephrine

Epinephrine 1mg 1:10000 (10cc) per dose

Andre navn:
  • Adrenalin

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Survival to hospital discharge
Tidsramme: Through study completion (up to 5 years)

Individuals discharged alive from hospital
Through study completion (up to 5 years)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Return of spontaneous circulation in out-of-hospital setting
Tidsramme: Through study completion (up to 5 years)

Return of spontaneous circulation in the field
Through study completion (up to 5 years)
Survival to emergency department arrival
Tidsramme: Through study completion (up to 5 years)

Individuals alive upon arrival to a hospital emergency department
Through study completion (up to 5 years)
Survival to admission with death prior to discharge
Tidsramme: Through study completion (up to 5 years)

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
Tidsramme: Through study completion (up to 5 years)

Individuals discharged alive from hospital to a care facility
Through study completion (up to 5 years)
Modified Rankin Scale (mRS) score
Tidsramme: 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)
12+/-3 months
Health Utility Index-3 (HUI-3) score
Tidsramme: 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)
12+/-3 months
Hospital Anxiety and Depression Scale score
Tidsramme: 12+/-3 months

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
Tidsramme: Through study completion (up to 5 years)

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
Tidsramme: Through study completion (up to 5 years)

Length of time an individual remained in a crucial care unit (length in days)
Through study completion (up to 5 years)
Survival post-arrest
Tidsramme: Up to 5 years

Survival following hospital discharge, up to 5 years
Up to 5 years
Recurrent cardiac arrest(s)
Tidsramme: Up to 5 years

Number of cardiac arrests following the index arrest
Up to 5 years
ICD implant post-arrest
Tidsramme: Up to 5 years

Whether an implantable cardioverter defibrillator was implanted post-arrest
Up to 5 years
Cardiovascular re-hospitalization(s)
Tidsramme: Up to 5 years

Number of cardiovascular re-hospitalizations
Up to 5 years
All-cause re-hospitalizations(s)
Tidsramme: Up to 5 years

Number of re-hospitalizations for any reason
Up to 5 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Unity Health Toronto

Samarbeidspartnere

Canadian Institutes of Health Research (CIHR)

Etterforskere

  • Hovedetterforsker: Paul Dorian, MD, MSc, Unity Health Toronto
  • Hovedetterforsker: Steve Lin, MD, MSc, Unity Health Toronto

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. mai 2023

Primær fullføring (Antatt)

1. desember 2028

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

7. november 2018

Først innsendt som oppfylte QC-kriteriene

30. januar 2019

Først lagt ut (Faktiske)

1. februar 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. september 2026

Sist bekreftet

1. desember 2025

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EpiDOSE Protocol Version 4.0

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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