Welcome to the Hydrogen-FAST Study Website
Starting in Fall 2023, we will be starting a research study of an investigational new therapy that may actively treat brain and kidney injury that results from a cardiac arrest requiring emergency ECMO Support. The research trial will take place in the cardiac intensive care units (CICU) at Boston Children’s Hospital, which is the leading institution, and other sites. Any patient who is admitted to one of these centers and who has a cardiac arrest requiring ECMO may be eligible for the research study.
Since cardiac arrest requiring ECMO is an emergency cannot be predicted, this research study is authorized by the FDA and IRB to use a special consent process for this potentially life-saving intervention. You can learn more by visiting the Study Details page or by visiting clinicaltrials.gov.
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).
Study overview
A cardiac arrest is an unexpected and rare event in which the heart stops effectively beating, causing blood in the body to stop flowing. This is a true medical emergency, and standard treatments include CPR, a breathing tube with oxygen, and medications to help the heart start beating effectively again. When these efforts are ineffective, some patients have to be rescued using a heart-lung bypass machine known as ECMO. This process is called ECPR. Unfortunately, fewer than 50% of patients survive an ECPR event, largely due to the oxygen deprivation that occurs during the ECPR event itself.
A research study is taking place in the cardiac intensive care units (CICUs) at Boston Children’s Hospital and other sites to examine the use of small concentrations of hydrogen gas as a way to protect the brain, kidneys, and other organs from the injury that occurs from an ECPR event. Animal studies have shown that hydrogen significantly decreases injury to the brain and kidneys in this setting. A research study at Boston Children’s Hospital also showed that breathing this dose of hydrogen gas was well tolerated in healthy adults.
If a patient experiences an ECPR event, he or she may be enrolled in the Hydrogen-FAST Study. Patients who are enrolled in the research study will be randomly assigned to treatment with hydrogen in addition to all standard of care treatments or to standard of care treatments without hydrogen. Two out of three patients will be treated with hydrogen.
If enrolled, your child's safety will continue to be top priority, and he or she will receive all treatments he or she would otherwise get.
Because cardiac arrest that requires ECPR is a life-threatening emergency, and because hydrogen must be used immediately, your doctors and nurses need to focus on taking care of your child, so they may not be able to discuss the study with you at the time the medication is needed. Whenever possible, research study personnel will try to obtain your consent, or at least provide you an opportunity to object before the drug is started. In every case, after your child is enrolled in the research study, study personnel will promptly discuss the research with you in further detail, and you can be removed from the research trial anytime at your request. We are available anytime at 857-299-4233 or hydrogenfast@childrens.harvard.edu to answer any questions.
If you do not wish your child to participate, you may opt out at any time before the medication is given, including now by filling out this brief form. You can also click here for more information on opting out.