Testing inhaled hydrogen gas for cardiac arrest treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to evaluate the feasibility and safety of administering inhaled hydrogen gas (H2) as a rescue therapy during extracorporeal cardiopulmonary resuscitation (ECPR) for patients experiencing refractory cardiac arrest. Patients in the cardiac ICU will be randomized to receive standard therapy with or without 2% hydrogen gas for 72 hours. The study seeks to address the significant neurological and renal injuries that often follow cardiac arrest and ECPR by potentially reducing cellular damage through hydrogen administration. Preclinical data suggest that hydrogen inhalation may improve outcomes in similar scenarios, making this an innovative approach to a critical medical challenge.

Why it matters

Who can join: the full rules

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.

Where it's running

• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting
• Children's National Hospital
  Washington D.C., District of Columbia, United States Not yet recruiting
• Children's Mercy Kansas City
  Kansas City, Missouri, United States Not yet recruiting
• Primary Children's Hospital
  Salt Lake City, Utah, United States Not yet recruiting

Study contacts

• Principal investigator: John N Kheir, MD — Associate Professor of Pediatrics, Harvard Medical School
• Study coordinator: John N Kheir, MD
• Email: john.kheir@childrens.harvard.edu
• Phone: 8576368890

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Identifying factors that predict survival and neurological outcomes in patients treated with E-CPR.

  This study looks at patients who received ECMO treatment after a cardiac arrest to see what factors can help predict their survival and brain recovery.

  Recruiting Sahlgrenska University Hospital · Gothenburg · NCT04198792

• Heartsight helps caregivers of kids after cardiac arrest manage uncertainty and fear

  This pilot trial tests if the Heartsight information program is acceptable and helpful for caregivers of children who recently had a cardiac arrest.

  Recruiting Children's Hospital of Philadelphia · Philadelphia, Pennsylvania · NCT07707037

• Brain blood flow and brain regulation in critically ill kids

  This study tests how blood flow in the brain behaves in critically ill children using a noninvasive ultrasound (TCD) to see if brain autoregulation patterns relate to outcomes.

  Recruiting University of Wisconsin, Madison · Madison, Wisconsin · NCT07613918

• Cardiopulmonary resuscitation with balloon occlusion of the descending aorta for hospitalized patients

  This trial will test whether adding a balloon occlusion of the descending aorta (REBOA) to standard ACLS helps people having an in-hospital cardiac arrest regain and keep a pulse.

  Recruiting Insel Gruppe AG, University Hospital Bern · Bern · NCT07434726

• Preventing reperfusion injury during ST-elevation heart attack using Xolatryp

  This will test whether a single 6-hour IV infusion of Xolatryp given during primary PCI helps people having their first ST-elevation heart attack reduce heart muscle damage and improve short-term heart function.

  Recruiting at 5 sites Phase 2 Nyrada Pty Ltd · Kingswood, New South Wales and 7 other locations · NCT07362446

• Digital serious game to improve critical care nurses' targeted temperature management skills and situational awareness.

  We will test whether adding a digital serious game to regular lectures helps adult ICU nurses learn targeted temperature management and improve situational awareness.

  Recruiting National Taiwan University Hospital · Taipei, Taipei · NCT07239206

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.