Recruiting
Phase 1

Hydrogen Therapy

Sponsor:

Boston Children's Hospital

Code:

NCT05574296

Conditions

Cardiac Arrest

Extracorporeal Membrane Oxygenation

Reperfusion Injury

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Hydrogen

Usual care

Study Details

Brief summary:

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.

Conditions

Cardiac Arrest

Extracorporeal Membrane Oxygenation

Reperfusion Injury

Study ID

NCT05574296

Start date

Mar 4, 2024

Status verified date

Jul, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

INCLUSION CRITERIA

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Patients admitted to a cardiac intensive care unit at a participating site with cardiac comorbidity, including congenital heart disease, myocarditis, cardiac arrhythmia, or rejection of a transplanted heart.
2. Patients are anticipated to be between birth to 18 years of age, although occasionally a patient over the age of 18 may be enrolled.
3. Patient experiencing a refractory cardiac arrest >5 minutes and receiving ongoing CPR in the ICU, cardiac catheterization lab, or cardiac operating room.
4. The decision made by the clinical team to resuscitate from ongoing, refractory cardiac arrest using ECPR due to a lack of other available options.

EXCLUSION CRITERIA

Meeting any of the following criterion renders the patient ineligible for the trial:

1. Enrollment in the opt-out program.
2. Patients known to be pregnant.
3. Patients who are prisoners.
4. Prior ECPR episode during admission (whether or not they were enrolled in the trial).
5. Enrollment does not occur within 6 hours of the decision to resuscitate using ECPR.

Note that ECMO cannulation without preceding CPR does not qualify as ECPR and such patients will not be included.

Study Design

Enrollment

53 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Hydrogen

Hydrogen gas (2%) in air or oxygen administered for 72 hours via ventilator and ECMO membrane. Oxygen concentration titrated per clinical team.

Usual care

Usual care post-ECPR event, including targeted temperature management.

Primary outcome measure

  • Feasibility of hydrogen administration (primary) [ Time Frame: 72 hours ]
  • Safety of hydrogen administration [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

John Kheir, MD

More Information

Sponsor

Boston Children's Hospital

Last update posted

Jul 3, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2025-07-03.