Hydrogen's Feasibility and Safety as a Therapy in ECPR

Launched by BOSTON CHILDREN'S HOSPITAL · Oct 6, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the use of inhaled hydrogen gas as a potential treatment for patients experiencing cardiac arrest who require a special type of life support called extracorporeal cardiopulmonary resuscitation (ECPR). The goal is to see if using hydrogen gas can help improve safety and effectiveness during this critical time. Patients in the cardiac intensive care unit who are facing severe heart problems and have been in cardiac arrest for more than five minutes may be eligible to participate. This includes children and young adults up to 18 years old with various heart conditions.

If a patient is chosen for the trial, they will be randomly assigned to receive standard care either with or without the addition of hydrogen gas for up to 72 hours. It's important to know that not everyone will qualify; for example, individuals who are pregnant or have been in prison cannot participate. The trial is currently recruiting participants, and it focuses on providing new insights into how inhaled hydrogen might help in emergency heart situations.

Gender

ALL

Eligibility criteria

• • INCLUSION CRITERIA
• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• • 1. 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.
• • 2. Patients are anticipated to be between birth to 18 years of age, although occasionally a patient over the age of 18 may be enrolled.
• • 3. Patient experiencing a refractory cardiac arrest \>5 minutes and receiving ongoing CPR in the ICU.
• • 4. The decision made by the clinical team to resuscitate from ongoing, refractory cardiac arrest using ECPR due to a lack of other available options.
• • EXCLUSION CRITERIA
• Meeting any of the following criterion renders the patient ineligible for the trial:
• • 1. Enrollment in the opt-out program.
• • 2. Patients known to be pregnant.
• • 3. Patients who are prisoners.
• • 4. Prior ECPR episode during admission (whether or not they were enrolled in the trial).
• • 5. Enrollment does not occur within 2 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.