Actively Recruiting
Hydrogen's Feasibility and Safety as a Therapy in ECPR
Led by Boston Children's Hospital · Updated on 2025-07-03
53
Participants Needed
4
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Hydrogen's Feasibility and Safety as a Therapy in ECPR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients admitted to a cardiac intensive care unit with cardiac conditions such as congenital heart disease, myocarditis, arrhythmia, or transplanted heart rejection
- Patients anticipated to be from birth to 18 years old, with occasional enrollment of patients over 18
- Patients experiencing refractory cardiac arrest lasting more than 5 minutes and receiving ongoing CPR in ICU, catheterization lab, or operating room
- Clinical decision to resuscitate using extracorporeal cardiopulmonary resuscitation (ECPR) due to lack of other options
You will not qualify if you...
- Enrollment in the opt-out program
- Known pregnancy
- Prisoner status
- Prior ECPR episode during the same admission
- Enrollment not occurring within 6 hours of the decision to use ECPR
- ECMO cannulation without preceding CPR (does not qualify as ECPR)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Not Yet Recruiting
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Children's Mercy Kansas City
Kansas City, Missouri, United States, 64108
Not Yet Recruiting
4
Primary Children's Hospital
Salt Lake City, Utah, United States, 84132
Not Yet Recruiting
Research Team
J
John N Kheir, MD
CONTACT
V
Victoria Habet, DO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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