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Epinephrine Dose: Optimal Versus Standard Evaluation Trial

Study acronym: EpiDOSE
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2027 → Dec 2028
Enrollment reduced 67% 3790 → 1250 participants
See other at-risk trials from Unity Health Toronto

Record History

  1. Primary completion pushed from Dec 2027 to Dec 2028 Enrollment reduced: 3790 → 1250 participants · Study sites: 8 to 9 · Eligibility criteria expanded, about 11 words · 2 more Show 5 more changesShow less
    • Enrollment reduced: 3790 → 1250 participants
    • Study sites: 8 to 9
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 3 of 14 entries
    • Collaborators: 2 to 1
  2. Study sites: 3 to 8 Completion date: Jun 2028 to Dec 2028v7 Show 1 more changeShow less
    • Completion date: Jun 2028 to Dec 2028
  3. Study sites: 1 to 3 Eligibility criteria expanded, about 6 words · Study description expanded, about 8 wordsv6 Show 2 more changesShow less
    • Eligibility criteria expanded, about 6 words
    • Study description expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  4. Eligibility criteria shortened, about 1 wordv5 See this version in full on ClinicalTrials.gov ↗
  5. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Nov 2025 to Dec 2027 · Start date changed from estimate of Oct 2021 to May 24, 2023 · Study sites: 0 to 1 · 2 morev4 Show 5 more changesShow less
    • Primary completion date: Nov 2025 to Dec 2027
    • Start date changed from estimate of Oct 2021 to May 24, 2023
    • Study sites: 0 to 1
    • Completion date: Jan 2027 to Jun 2028
    • Eligibility criteria expanded, about 14 words

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: Nov 2024 to Nov 2025 Start date: Oct 2020 to Oct 2021 · Completion date: Jan 2026 to Jan 2027 · Eligibility criteria expanded, about 9 words · 1 morev3 Show 4 more changesShow less
    • Start date: Oct 2020 to Oct 2021
    • Completion date: Jan 2026 to Jan 2027
    • Eligibility criteria expanded, about 9 words
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Nov 2023 to Nov 2024 Start date: Oct 2019 to Oct 2020 · Completion date: Jan 2025 to Jan 2026 · Study description shortened, about 11 wordsv2 Show 3 more changesShow less
    • Start date: Oct 2019 to Oct 2020
    • Completion date: Jan 2025 to Jan 2026
    • Study description shortened, about 11 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT03826524
Lead Sponsor Unity Health Toronto
Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions Cardiac Arrest, Out-Of-Hospital, Sudden Cardiac Arrest, Ventricular Fibrillation, Ventricular Tachycardia-Pulseless
Enrollment 1,250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov