Hydrogen's Feasibility and Safety as a Therapy in ECPR
Recruiting now · Phase 1
Conditions studied: Cardiac Arrest, Extracorporeal Membrane Oxygenation, Reperfusion Injury
In brief
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 facts
- Study ID
- NCT05574296
- Run by
- Boston Children's Hospital
- People needed
- 53
- Starts
- 2024-03-04
- Expected to finish
- 2027-08-31
- Last updated by the study team
- 2025-07-03
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
- Children's National Hospital — Washington D.C., District of Columbia, United States
- Children's Mercy Kansas City — Kansas City, Missouri, United States
- Primary Children's Hospital — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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