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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 1
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% hydrogen in gases administered via the ventilator and ECMO membrane for 72 hours.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Washington, D.c.
Children's National Hospital
NOT_YET_RECRUITING
Washington D.c.
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Missouri
Children's Mercy Kansas City
NOT_YET_RECRUITING
Kansas City
Utah
Primary Children's Hospital
NOT_YET_RECRUITING
Salt Lake City
Contact Information
Primary
John N Kheir, MD
john.kheir@childrens.harvard.edu
8576368890
Backup
Victoria Habet, DO
Time Frame
Start Date: 2024-03-04
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 53
Treatments
Experimental: Usual care + H2 therapy
Hydrogen administered via mechanical ventilator and sweep gas into ECMO membrane for 72 hours
Active_comparator: Usual care
The current standard of care.
Related Therapeutic Areas
Sponsors
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov