Testing inhaled hydrogen gas for cardiac arrest treatment

Hydrogen's Feasibility and Safety as a Therapy in Extracorporeal Cardiopulmonary Resuscitation

This study is testing if breathing in hydrogen gas can help improve recovery for patients who have had a cardiac arrest and are receiving special life-saving treatment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sex: All
• Sponsor: Boston Children's Hospital (Academic / other)
• Locations: 4 sites (Washington D.C., District of Columbia and 3 other locations)
• Trial ID: NCT05574296 on ClinicalTrials.gov

What this trial studies

This project aims to evaluate the feasibility and safety of administering inhaled hydrogen gas (H2) as a rescue therapy during extracorporeal cardiopulmonary resuscitation (ECPR) for patients experiencing refractory cardiac arrest. Patients in the cardiac ICU will be randomized to receive standard therapy with or without 2% hydrogen gas for 72 hours. The study seeks to address the significant neurological and renal injuries that often follow cardiac arrest and ECPR by potentially reducing cellular damage through hydrogen administration. Preclinical data suggest that hydrogen inhalation may improve outcomes in similar scenarios, making this an innovative approach to a critical medical challenge.

Who should consider this trial

Good fit: Ideal candidates include patients aged birth to 18 years with cardiac comorbidities who are experiencing refractory cardiac arrest and are receiving ongoing CPR in the ICU.

Not a fit: Patients who are pregnant, prisoners, or have previously undergone ECPR during the same admission may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly improve survival rates and neurological outcomes for patients experiencing cardiac arrest.

How similar studies have performed: While preclinical studies have shown promising results with hydrogen inhalation in related conditions, this specific application in ECPR is novel and has not been extensively tested in human subjects.

Eligibility criteria

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.

Where this trial is running

Washington D.C., District of Columbia and 3 other locations

• Children's National Hospital — Washington D.C., District of Columbia, United States (Not_yet_recruiting)
• Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
• Children's Mercy Kansas City — Kansas City, Missouri, United States (Not_yet_recruiting)
• Primary Children's Hospital — Salt Lake City, Utah, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: John N Kheir, MD — Associate Professor of Pediatrics, Harvard Medical School
• Study coordinator: John N Kheir, MD

Conditions Cardiac Arrest; Extracorporeal Membrane Oxygenation; Reperfusion Injury