Medication Study For Children Having Heart Surgery
What is the purpose of this study?
This study will determine if intravenous citrulline given during cardiac surgery lowers the risk of high blood pressure in the lungs in children undergoing certain surgeries for repair of congenital heart problems.
Who will be included in this study?
Children and adolescents, birth to 18 years old, having surgery for a heart problem and who may be at risk for high blood pressure in the lungs after heart surgery, may be able to participate.
What is involved?
This study lasts for 48 hours, or until discharged from the Cardiac Intensive Care Unit (CICU). The study will stop once you or your child leaves the CICU. The following is a list of procedures that will take place during the study:
- Bolus dose of study medication in the operating room after start of cardiopulmonary bypass
- Continuous study infusion for 48 hours that will begin 4 hours after the bolus dose infused
- Echocardiogram at 24 and 48 hours following start of the continuous study medication
- Urine and blood work to check for levels prior to start of the medication, and after the bolus dose. 4, 6, 12, 24, and 48 hours after continuous infusion started
What are the benefits?
You or your child may or may not receive direct benefit from participating in this study. The biggest benefit is that your child may be helping out others that may be at risk of developing pulmonary hypertension following cardiac surgery.
Will I get all the facts about the study?
Parents and adult subjects will be given a consent form that thoroughly explains all of the details of the study. It includes all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns, and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until the parent/guardian or you, the participating subject, have signed the consent form and, if of age, the child has given at minimum his/her verbal agreement.
What are the risks?
Although people usually tolerate intravenous citrulline, there is a potential of side effects whenever you take medication. A detailed list of side effects will be provided to those patients interested in knowing more about the study.
What is the pay?
You will receive no payment or reimbursement for participation in the study. Study related medication and testing will be provided at no cost.
Who should I contact for more information?
Tracey Van Vliet, RN
Cincinnati Children’s Hospital Medical Center
Department of Cardiology, MLC 2003
3333 Burnet Avenue, Cincinnati, OH 45229-3039
Phone: 513-636-7847
tracey.vanvliet@cchmc.org
