Hydrogen's Feasibility and Safety as a Therapy in ECPR

NCT05574296 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IRB-P00043374
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (2)

• Feasibility of hydrogen administration (primary)

  Percentage of the first 72 consecutive post-arrest hours (starting at the time of first CPR initiation) in which H2 gas was administered via all of the applicable pathways (e.g. mechanical ventilator and ECMO membrane).

  72 hours

• Safety of hydrogen administration

  Incidence rate of SAEs of interest per day during the first 30 days post-randomization that have been classified as treatment-related or possibly treatment-related.

  30 days

Secondary Outcomes (5)

• Survival to hospital discharge

  From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months

• ICU length of stay

  From date of randomization until the date of first ICU discharge or date of death from any cause, whichever came first, assessed up to 12 months

• Hospital length of stay

  From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months

• Functional status score

  Calculated on admission to the hospital, at 24 h before cardiac arrest, at hospital discharge, and at 6 months post-randomization

• Feasibility of hydrogen administration (secondary)

  72 hours

Study Arms (2)

Usual care + H2 therapy

EXPERIMENTAL

Hydrogen administered via mechanical ventilator and sweep gas into ECMO membrane for 72 hours

Drug: Hydrogen; Other: Usual care

Usual care

ACTIVE COMPARATOR

The current standard of care.

Other: Usual care

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.

Also known as: H2 gas

Usual care + H2 therapy

Usual care OTHER

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

Also known as: Standard of care

Usual care; Usual care + H2 therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• 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.
• Patients are anticipated to be between birth to 18 years of age, although occasionally a patient over the age of 18 may be enrolled.
• Patient experiencing a refractory cardiac arrest \>5 minutes and receiving ongoing CPR in the ICU, cardiac catheterization lab, or cardiac operating room.
• The decision made by the clinical team to resuscitate from ongoing, refractory cardiac arrest using ECPR due to a lack of other available options.

You may not qualify if:

• Meeting any of the following criterion renders the patient ineligible for the trial:
• Enrollment in the opt-out program.
• Patients known to be pregnant.
• Patients who are prisoners.
• Prior ECPR episode during admission (whether or not they were enrolled in the trial).
• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (4)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

NOT YET RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

NOT YET RECRUITING

Primary Children's Hospital

Salt Lake City, Utah, 84132, United States

NOT YET RECRUITING

Related Publications (1)

• Habet V, DeWaard T, Boggs KM, Fetch A, Puente BN, Sleeper LA, Kheir JN. Hydrogen's Feasibility and Safety as a Therapy in Extracorporeal Cardiopulmonary Resuscitation (Hydrogen-FAST): study protocol for a trial of inhaled hydrogen gas as an adjunctive therapy in refractory cardiac arrest. Trials. 2025 Nov 7;26(1):481. doi: 10.1186/s13063-025-09217-7.

  PMID: 41204320 DERIVED

MeSH Terms

Conditions

Heart Arrest; Reperfusion Injury

Interventions

Hydrogen; Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Elements; Inorganic Chemicals; Gases; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• John N Kheir, MD

  Associate Professor of Pediatrics, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John N Kheir, MD

CONTACT

8576368890; john.kheir@childrens.harvard.edu

Victoria Habet, DO

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics, Harvard Medical School

Model Details: Randomized to usual care with or without treatment

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 10, 2022
• Study Start: March 4, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)