Cardiac ArrestPhase 1HydrogenFASTNCT05574296
Hydrogen's Feasibility and Safety as a Therapy in ECPR
A Phase 1 study testing Hydrogen in people with Cardiac Arrest and Extracorporeal Membrane Oxygenation, run by Boston Children's Hospital at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Arrest, Extracorporeal Membrane Oxygenation, Reperfusion Injury
- What is being tested?
- Hydrogen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Mar 2024to 31 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Victoria Habet, DO contact
United States4 sites, 4 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
John Kheir, MD, 8576368890, john.kheir@childrens.harvard.edu
John Kheir, MD
- Not yet recruiting
Children's Mercy Kansas City
Kansas City, Missouri, 64108
Niranjan Vijayakumar, MBBS, nvijayakumar1@cmh.edu
- Not yet recruiting
Primary Children's Hospital
Salt Lake City, Utah, 84132
Stephanie Goldstein, MD, stephanie.goldstein@hsc.utah.edu
- Not yet recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Bao (Robyn) Nguyen Puente, MD, bpuente@childrensnational.org
About this study
Official title: Hydrogen's Feasibility and Safety as a Therapy in Extracorporeal Cardiopulmonary Resuscitation
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.
Read the detailed description
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). Each year, 500,000 patients in the US suffer a cardiac arrest and a growing number of them are resuscitated using ECPR. However, neurologic and renal injury remain important resulting comorbidities. The pathophysiology of these often-devastating injuries is ischemia (inadequacy of blood flow, at times compounded by hypoxemia) followed by an abrupt reperfusion (ECMO flow initiation). Among patients with congenital heart disease (CHD) receiving ECPR, 52% either die prior to discharge or suffer severe neurologic impairment. Diatomic hydrogen (H2) administration during and following ECPR may chemically reduce the toxic mediators that directly damage cellular structures and improve neurologically intact survival.
Preclinical data. Several groups have described that H2 inhalation decreases injury when administered following ischemic stroke, myocardial infarction, and cardiac arrest in rodents. Our group demonstrated that inhalation of 2.4% H2 for 24 hours following an experimental swine ischemia-reperfusion injury (as occurs in ECPR) improved neurologic scores, decreased seizures, diminished T2 white matter injury volume by 65%, and improved serum creatinine. Safety study in healthy participants. Under an investigator-initiated IND, we exposed 8 healthy adult participants to up to 72 hours of 2.4% H2 inhalation via high flow nasal cannula, finding no adverse effects on markers of hepatic, renal, cardiac or pulmonary function and no clinically significant symptoms reported. Having received a favorable pre-IND review from the FDA, we propose a two-center early phase study of H2 administration in patients with CHD receiving ECPR.
Study overview. We propose an early-phase randomized trial entitled the 'Hydrogen FAST Trial' (Hydrogen's Feasibility And Safety as a Therapeutic agent). The trial will have a 3-patient vanguard phase and 53 patients with CHD experiencing ECPR randomly assigned in a 3:2 (32/21) ratio to either usual care plus 2% H2 gas for 72 hours or to usual care. Patients will be recruited from two sites. We will primarily examine feasibility and safety (severe adverse events, independently adjudicated), as well as some indicators of efficacy.
Hypotheses. Primary feasibility endpoint: We hypothesize that H2 gas will be administered for a mean of >90% of the first 72 consecutive post-arrest hours in patients so-assigned. Primary safety endpoint: We hypothesize that compared with patients receiving usual post-arrest care, patients receiving H2 will not exceed the treatment-related SAE rate of the usual care group by >12.5% in the 30 days following randomization. Secondary feasibility endpoint: We hypothesize that H2 gas will be administered for a mean of >90% of the first 72 consecutive hours post-H2 initiation in patients so-assigned.
- Being tested
- Hydrogen, Usual care
- Medical subject headings
- Heart Arrest, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrogenDrug
Also called H2 gas
Hydrogen gas (2%) in air or oxygen administered for 72 hours via ventilator and ECMO membrane. Oxygen concentration titrated per clinical team.
Usual careOther
Also called Standard of care
Usual care post-ECPR event, including targeted temperature management.
| Study group | Role | What they receive |
|---|---|---|
| Usual care + H2 therapy | Experimental | Hydrogen administered via mechanical ventilator and sweep gas into ECMO membrane for 72 hours Receives: Drug: Hydrogen; Other: Usual care |
| Usual care | Active comparator | The current standard of care. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 30 days
Secondary outcomes (5)
Survival to hospital discharge
Survival to hospital discharge
Measured: 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
Duration of ICU stay until first transfer out of ICU
Measured: 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
Duration of hospital stay until first hospital discharge
Measured: 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
Functional status score computed based on a detailed review of neurology notes, primary team notes, nursing notes and physical exam documentation by two independent investigators.
Measured: 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)
Percentage of the first 72 consecutive hours post-H2 initiation in which H2 gas was administered via all of the applicable pathways (e.g. mechanical ventilator and ECMO membrane).
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start4 Mar 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized to usual care with or without treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Kheir, Boston Children's Hospital
- Investigators
- John N Kheir, MD, Principal investigator, Associate Professor of Pediatrics, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574296
- Sponsor's protocol ID
- IRB-P00043374
- Acronym
- HydrogenFAST
- Status last verified
- Jul 2025
- First submitted
- 5 Oct 2022
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41204320
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrogen's Feasibility and Safety as a Therapy in Extracorporeal Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT05574296
- Acronym / sponsor ID
- HydrogenFAST / IRB-P00043374
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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). Each year, 500,000 patients in the US suffer a cardiac arrest and a growing number of them are resuscitated using ECPR. However, neurologic and renal injury remain important resulting comorbidities. The pathophysiology of these often-devastating injuries is ischemia (inadequacy of blood flow, at times compounded by hypoxemia) followed by an abrupt reperfusion (ECMO flow initiation). Among patients with congenital heart disease (CHD) receiving ECPR, 52% either die prior to discharge or suffer severe neurologic impairment. Diatomic hydrogen (H2) administration during and following ECPR may chemically reduce the toxic mediators that directly damage cellular structures and improve neurologically intact survival.
Preclinical data. Several groups have described that H2 inhalation decreases injury when administered following ischemic stroke, myocardial infarction, and cardiac arrest in rodents. Our group demonstrated that inhalation of 2.4% H2 for 24 hours following an experimental swine ischemia-reperfusion injury (as occurs in ECPR) improved neurologic scores, decreased seizures, diminished T2 white matter injury volume by 65%, and improved serum creatinine. Safety study in healthy participants. Under an investigator-initiated IND, we exposed 8 healthy adult participants to up to 72 hours of 2.4% H2 inhalation via high flow nasal cannula, finding no adverse effects on markers of hepatic, renal, cardiac or pulmonary function and no clinically significant symptoms reported. Having received a favorable pre-IND review from the FDA, we propose a two-center early phase study of H2 administration in patients with CHD receiving ECPR.
Study overview. We propose an early-phase randomized trial entitled the 'Hydrogen FAST Trial' (Hydrogen's Feasibility And Safety as a Therapeutic agent). The trial will have a 3-patient vanguard phase and 53 patients with CHD experiencing ECPR randomly assigned in a 3:2 (32/21) ratio to either usual care plus 2% H2 gas for 72 hours or to usual care. Patients will be recruited from two sites. We will primarily examine feasibility and safety (severe adverse events, independently adjudicated), as well as some indicators of efficacy.
Hypotheses. Primary feasibility endpoint: We hypothesize that H2 gas will be administered for a mean of >90% of the first 72 consecutive post-arrest hours in patients so-assigned. Primary safety endpoint: We hypothesize that compared with patients receiving usual post-arrest care, patients receiving H2 will not exceed the treatment-related SAE rate of the usual care group by >12.5% in the 30 days following randomization. Secondary feasibility endpoint: We hypothesize that H2 gas will be administered for a mean of >90% of the first 72 consecutive hours post-H2 initiation in patients so-assigned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized to usual care with or without treatment
| Arm | Type | Receives |
|---|---|---|
| Usual care + H2 therapy | Experimental | Drug: Hydrogen, Other: Usual careHydrogen administered via mechanical ventilator and sweep gas into ECMO membrane for 72 hours |
| Usual care | Active comparator | Other: Usual careThe current standard of care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrogenAlso: H2 gasHydrogen gas (2%) in air or oxygen administered for 72 hours via ventilator and ECMO membrane. Oxygen concentration titrated per clinical team. | Drug | Usual care + H2 therapy |
| Usual careAlso: Standard of careUsual care post-ECPR event, including targeted temperature management. | Other | Usual care, Usual care + H2 therapy |
Primary outcome
Feasibility of hydrogen administration (primary)
Time frame: 72 hours
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).
Safety of hydrogen administration
Time frame: 30 days
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.
5 secondary outcomes
Survival to hospital discharge
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Derived from this study: PubMed 41204320Habet 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victoria Habet, DO contact
John N Kheir, MD principal investigator
Associate Professor of Pediatrics, Harvard Medical School
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydrogen in people with Cardiac Arrest and Extracorporeal Membrane Oxygenation, run by Boston Children's Hospital at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John N Kheir, MD (8576368890, john.kheir@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of hydrogen administration (primary) (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05574296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.