Hydrogen's Feasibility and Safety as a Therapy in ECPR

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Boston Children's Hospital
Study ID
NCT05574296
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Cardiac Arrest
  • Extracorporeal Membrane Oxygenation
  • Reperfusion Injury

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hydrogen — DRUG
    Hydrogen gas (2%) in air or oxygen administered for 72 hours via ventilator and ECMO membrane. Oxygen concentration titrated per clinical team.
  • Usual care — OTHER
    Usual care post-ECPR event, including targeted temperature management.

Study Details

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.

Key Dates

Start date
Mar 4, 2024
Status verified
Jul 2025
Primary completion
Mar 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
53 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Usual care + H2 therapy
    Hydrogen administered via mechanical ventilator and sweep gas into ECMO membrane for 72 hours
  • Active Comparator: Usual care
    The current standard of care.

Primary Outcome Measure

Feasibility of hydrogen administration (primary) [ Time Frame: 72 hours ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010
Bao (Robyn) Nguyen Puente, MD
[email protected]
Boston Children's HospitalBostonMassachusetts02115
John Kheir, MD
[email protected]
8576368890
John Kheir, MD (PRINCIPAL_INVESTIGATOR)
Victoria Habet, DO (SUB_INVESTIGATOR)
Children's Mercy Kansas CityKansas CityMissouri64108
Niranjan Vijayakumar, MBBS
[email protected]
Primary Children's HospitalSalt Lake CityUtah84132
Stephanie Goldstein, MD
[email protected]

Find similar trials in Washington D.C., DC

By research site
Children's National Hospital· Washington D.C., DCBoston Children's Hospital· Boston, MAChildren's Mercy Kansas City· Kansas City, MOPrimary Children's Hospital· Salt Lake City, UT

Related Studies