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Hydrogen's Feasibility and Safety as a Therapy in ECPR

Study acronym: HydrogenFAST
StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Primary endpoints revised (2)v6 Show 4 more changesShow less
    • Study sites: 1 to 4
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: 4 to 5
    • Study description expanded, about 28 words
  2. Study description shortened, about 7 words
    • Eligibility criteria shortened, about 4 words
    • Collaborators shortened, about 4 words
    v5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2023 to Mar 4, 2024
    • Study sites: 0 to 1
    v4
  4. Start date: Sep 1, 2023 to Dec 1, 2023
    • Study description revised
    • Study title revised
    v3
  5. Eligibility criteria expanded, about 86 wordsv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this project is to test the feasibility and safety of inhaled hydrogen gas (H2) administration as a rescue therapy during cardiac arrest requiring extracorporeal cardiopulmonary resuscitation (ECPR, i.e. mechanical circulatory support). Under exemption from informed consent, patients undergoing refractory cardiac arrest in the cardiac ICU at a participating center will be randomized to standard therapy with or without the administration of 2% hydrogen in gases administered via the ventilator and ECMO membrane for 72 hours.
Trial Details
NCT Number NCT05574296
Lead Sponsor Boston Children's Hospital
Conditions
(from sponsor)		 Cardiac Arrest, Extracorporeal Membrane Oxygenation, Reperfusion Injury
Related terms Heart Arrest, Reperfusion Injury
Enrollment 53 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov