Hydrogen's Feasibility and Safety as a Therapy in ECPR
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:
🦠 Cardiac Arrest 🦠 Extracorporeal Membrane Oxygenation 🦠 Reperfusion Injury
🗓️ Study Start (Actual) 4 March 2024
🗓️ Primary Completion (Estimated) 31 March 2027
✅ Study Completion (Estimated) 31 August 2027
👥 Enrollment (Estimated) 53
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

  • 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 Boston Children's Hospital or Texas Children's Hospital 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.
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 October 2022
  • First Submitted that Met QC Criteria 6 October 2022
  • First Posted 10 October 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 March 2024
  • Last Update Posted 12 March 2024
  • Last Verified March 2024