Hydrogen's Safety and Efficacy as a Therapy in ECPR

• Status: Not yet recruiting
• Trial end date: 2027-08-31
• Target enrollment: 0
• Participant gender: All

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). 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 2.4% hydrogen in gases administered via the ventilator and ECMO membrane for 72 hours.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital
• Collaborator: Baylor College of Medicine

Criteria

INCLUSION CRITERIA

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Patients with congenital heart disease, which will be broadly defined, including myocarditis, channelopathies, transplant rejection.

2. Patient experiencing a cardiac arrest >5 minutes and receiving ongoing CPR in a cardiac intensive care unit at either Boston Children's Hospital or Texas Children's Hospital.

3. The decision made to resuscitate using ECPR.

EXCLUSION CRITERIA

1. Enrollment in the opt-out program.

2. Randomization is not expected to occur within 2 hours of the decision to resuscitate using ECPR. (This is to exclude patients who are not randomized within 2 hours of ECPR.)