N-Acetylcysteine in Neonatal Congenital Heart Surgery (INACT Study)
Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine whether intravenous N-acetylcysteine (also known as
Acetadote), an antioxidant medication that has been used for years to treat Tylenol overdose,
helps prevent heart dysfunction in the early postoperative period following congenital heart
surgery. Children undergoing major heart surgery, such as the arterial switch operation,
routinely develop temporary heart dysfunction in the first 12-24 hours after surgery. This
heart dysfunction may be severe and contributes to an increased risk for death or prolonged
hospitalization. Current standard treatments include intravenous medications such as
dopamine, epinephrine, and vasopressin that support your child's blood pressure and heart
function. Unfortunately, high doses of these medications have the potential to cause severe
side effects including loss of fingers and toes, liver and kidney dysfunction, and heart
rhythm abnormalities. Our goal is to find a way to reduce heart dysfunction after major heart
surgery in order to promote a smoother postoperative period, and reduce the risks associated
with heart operations in children.