Hydrogen-FAST Study
Children’s National Hospital 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 be conducted in the Cardiac Intensive Care Unit (CICU) at Children’s National, as well as at Boston Children’s Hospital, the lead institution. 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 that cannot be predicted, this research study is authorized by the Food and Drug Administration (FDA) and Institutional Review Board (IRB) to use a special consent process for this potentially life-saving intervention.
Study Overview
A cardiac arrest is an unexpected and rare event in which the heart stops 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 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 who have a cardiac arrest and are placed on ECMO survive, largely due to the lack of oxygen that occurs during the cardiac arrest.
This research study examines 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 a cardiac arrest. Preclinical 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 has a cardiac arrest and is placed on ECMO, 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.
Study Leadership
At Children's National Hospital, Bao “Robyn” Puente, MD, is the principal investigator leading this study, and John Berger, MD, is the co-investigator supporting this study. Nationwide, this research study is led John Kheir, MD, associate professor of pediatrics at Harvard Medical School. The research trial is funded by the National Institutes of Health (NIH).
Contact Information
If you would like to speak with a research study team member at any time, please contact us by email at hydrogenfast@childrensnational.org or by phone at 202-476-5414.
If you would like to opt-out of the research trial, please complete this form. You can also reach out to our team by email or phone.
Hydrogen-FAST Clinical Trial
The Clinicaltrials.gov site has detailed information about the Hydrogen-FAST clinical trial.