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โ† Trials
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Hydrogen's Feasibility and Safety as a Therapy in ECPR

RecruitingPhase 1Ages any - anyAllBoston Children's Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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, cardiac catheterization lab, or cardiac operating room. 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 6 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.
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What it tests

  • Hydrogen
  • Usual care
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Where

4 sites
Children's National Hospital
Washington D.C., United States
Boston Children's Hospital
Boston, United States
Children's Mercy Kansas City
Kansas City, United States
Primary Children's Hospital
Salt Lake City, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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