Hydrogen’s Feasibility and Safety as a Therapy in ECPR (HydrogenFAST)
University of Utah Health and Primary Children’s Hospital is conducting a research study of an investigational new therapy. The new therapy may actively treat brain and kidney injury after a sudden death event (cardiac arrest).
A cardiac arrest is an unexpected and rare event. During cardiac arrest, the heart stops beating effectively. This prevents blood flow to the body. There are standard treatment options for cardiac arrest:
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CPR
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Breathing support often with a breathing tube and oxygen
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Medications
If these interventions do not help the heart start beating again, patients may be supported with a heart-lung bypass machine called ECMO.
This process is called ECPR. ECPR stands for extracorporeal cardiopulmonary resuscitation. Sadly, less than 50% of patients survive ECPR. Many patients that survive ECPR have significant injury to their organs, including their brain and kidneys. This damage is caused by a lack of oxygen that occurs during a cardiac arrest event.
There is currently no way to actively treat the lack of oxygen injury that occurs because of cardiac arrest.
The University of Utah and Primary Children’s Hospital is joining two other prominent pediatric centers to examine the use of small concentrations of hydrogen gas as a way to protect the brain and other organs from injury during ECPR. This trial is sponsored by the National Institutes of Health.
Study Details
We will be testing a treatment called Hydrogen (H2). Hydrogen is the lightest and most abundant molecule in the universe. It has no smell or color and reacts with oxygen to form water. When a lack of oxygen occurs in the body, tissue and organ cells use oxygen in a toxic way. They create an oxygen species called radicals that directly damage the body. Hydrogen soaks up radicals to make water. This makes the toxic oxygen species no longer harmful.
We are examining how possible it is to use hydrogen in a complex environment after an ECPR event. We are also checking for any adverse events that may be related to using hydrogen this way. (No other existing studies have reported adverse events or problems caused by administering hydrogen.) We are also looking for signs that hydrogen decreased damage to the brain, kidneys, or other organs.
How the Study Works
The research trial will only occur in the cardiac intensive care unit (CICU) at Primary Children’s Hospital. It is currently enrolling at Boston Children’s Hospital and Children’s National Hospital. To participate in the trial, you must meet specific criteria:
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Admitted to the CICU at Primary Children’s Hospital
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Have a cardiac arrest lasting longer than 5 minutes requiring ECMO support (<1% of CICU admissions)
Study Groups
Participants in this study are put at random (by chance) into one of two groups:
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Hydrogen gas— 2% hydrogen gas will be given to the patient through the ventilator (breathing machine) and through the ECMO circuit for three days, starting within two hours of the ECPR event. Two out of three patients enrolled in this study will be treated with hydrogen.
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No hydrogen gas—One out of three patients enrolled in this study will not receive hydrogen.
Both groups will receive standard, excellent care by their medical teams. Your child’s health and wellbeing is our priority. Participating in this study will not change the treatments your child would otherwise get.
What Happens During the Study
If a patient’s ICU team decides the patient needs to be supported with ECMO after a cardiac arrest (i.e. undergo ECPR), the patient may be enrolled in the HydrogenFAST study immediately. Hydrogen is most effective when started immediately and must be given within two hours of the event. Patients who are enrolled in this trial will be randomly assigned to be treated with 2% hydrogen or not. This will start as soon as possible after CPR and will continue for 72 hours.
Patients will be followed for 30 days after the ECPR event by our research team who will work alongside your clinical team. Your child’s medical chart will be reviewed six months after the event.
Benefits & Risks
Risks
There are no known risks to administering this small concentration of hydrogen gas through the ventilator and/or ECMO circuit to patients after a cardiac arrest. When this small concentration of hydrogen was given to healthy adults, there were no side effects or problems seen. The trial will be following the safety of the patients enrolled closely.
Benefits
It is not known whether your child would benefit from being in this study. However, in multiple animal studies, and one study from Japan in adults following a cardiac arrest, hydrogen gas was shown to be safe. It improved survival, and improved neurologic outcomes (less brain injury).
It is possible that patients enrolled in this trial and randomized to receive hydrogen would directly benefit by having less brain and/or other organ injury.
Exception From Informed Consent & the HydrogenFAST Study
More Information on Exception From Informed Consent (EFIC)
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Learn more about EFIC and how this study prepared for this research trial at Boston Children’s Hospital.
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See guidance from the FDA on EFIC trials and exception from informed consent requirements for emergency research.
Cardiac arrest requiring ECMO is an emergency. It cannot be predicted. The treatment we are testing must be started immediately after the CPR event. This is a highly medically complex, intense, and emotional time. It is not practical to obtain informed consent from the parent or guardian to participate in this research study during this high stress situation.
In situations like this, there is a special set of government rules that allows studies to include patients with an exception from informed consent under specific circumstances:
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The circumstances are life threatening, and treatment is not known.
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The treatment being tested could help the patient and provide potential benefits.
It is not possible to get permission from the patient because of their medical condition or from the person’s guardian because of the very short time required to treat the medical problem.
How Would I Know If My Child Were Enrolled in This Study?
After your child is enrolled in the research trial, study personnel will discuss the research study with you as soon as possible. This discussion will be in consultation with your child’s clinical team.
Your child can be removed from the trial at any time without consequence. After enrollment, you will get a post-enrollment flyer where you can learn additional information about the study and hydrogen treatment.
Any patient whose family choses to remove them from the trial will be removed immediately, including stopping the hydrogen gas treatment.
Opt Out
If you would like to opt-out of this research trial, please fill out this form. Your child will wear a bracelet that says “NO HYDROGEN” when admitted to Primary Children’s Hospital. An accompanying sign will be placed at their bedside. This ensures that if your child has a sudden cardiac arrest requiring ECMO, they will not be enrolled in the study and will not receive hydrogen.
Contact Us
If you would like to give us feedback, ask questions, or opt out of this trial, we are available at 801-662-2465 or cccp.research@hsc.utah.edu.
More Information
Study Team
This research study is led by John Kheir, MD, Associate Professor of Pediatrics at Harvard Medical School, a Senior Staff Physician in the Cardiac Intensive Care Unit, and the Director of the Heart Center’s Translational Research Lab. The research trial has been funded by the National Institutes of Health (NIH).
Leadership Team at the University of Utah & Primary Children’s Hospital
Stephanie Goldstein, MD
Site Principal Investigator, University of Utah and Primary Children’s Hospital
Assistant Professor of Pediatric Critical Care
Cardiac Intensive Care Unit, Primary Children’s Hospital
Cristina Mamolea, MD
Site Co-Investigator, University of Utah and Primary Children’s Hospital
Assistant Professor of Pediatric Critical Care
Cardiac Intensive Care Unit, Primary Children’s Hospital
Leadership Team at Boston Children’s Hospital
John N. Kheir, MD
Lead Principal Investigator
Study Sponsor/IND Holder
Director, Clinical Coordinating Center
Site Principal Investigator, Boston Children’s Hospital
Associate Professor of Pediatrics, Harvard Medical School
Senior Staff Physician, Cardiac Intensive Care Unit, Boston Children’s Hospital
Founding Director, Translational Research Lab, Boston Children’s Hospital Heart Center
Lynn A. Sleeper, ScD
Director, Data Coordinating Center
Associate Professor of Pediatrics, Harvard Medical School
Scientific Director, Division of Clinical Research, Department of Cardiology, Boston Children’s Hospital