Hydrogen's Feasibility and Safety as a Therapy in ECPR
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Hydrogen
- Usual care
Treatment groups
53 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov