Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about how well we predict the risk of poor health outcomes in children. We also want to look at the development of organ injury in children who are having surgery for the correction of heart disease.
We hope to develop a tool that would allow us to better counsel families regarding risk to their children prior to surgery.
What will happen in the study?
If your child qualifies for this study, and you decide to participate, he/she will be in this study for about 24 hours after their surgery.
The following is a list of the tests and procedures that will happen to your child during the study:
- Review of medical records: information will be reviewed prior to and throughout the hospital stay
- Blood samples: collected about 4 and 12 hours after surgery from a special intravenous (IV) catheter placed as a routine part of your child's surgery
- Urine sample: collected about 4 hours after surgery from an existing catheter
The blood samples will be collected when your child will already be having blood drawn for normal post-operative care. Drawing blood from the catheters is painless for your child.
If your child’s doctor or surgeon does not think he/she needs an IV catheter as part of their surgery, the research team will not place one for this study.
Parents, guardians and/or participants will be given a consent form that thoroughly explains all the details of the study. A member of the study staff will review the consent form with you and/or your child and will be sure that all your questions are answered.
What are the good things that can happen from this research?
Your child may not receive a direct medical benefit from being in this study right now.
However, when we finish the study, we hope to know more about the risk of congenital heart surgery and our ability to predict which children are at greater risk of organ injury after surgery. This may help other children with congenital heart disease later on.