Study of Possible Brain Hormone Problems After Open Heart Surgery in Infants

Stopped early

Conditions studied: Congenital Heart Disease

In brief

The goal of this study is to evaluate specific hormone levels in children undergoing heart surgery in order to identify patterns associated with any unstable vital signs. The data collected will provide preliminary answers to the question "Are hormone values a determining factor for drug administration and dosing levels?" and help establish the benefits of routine steroid and hormone administration. Sixty subjects will be enrolled. Blood samples will be drawn before the surgery,and again nine hours after surgery for analysis. Other patient data such as medications, vital signs, routine lab values and treatments will also be analyzed. As our current standard of care includes routine doses of steroids, we believe this study will increase our general knowledge and improve the care of these critically ill children. The study will also provide the foundation needed for grant support from the American Heart Association, allowing for future larger scale studies.

Key facts

Study ID

NCT00850720

Run by

Emory University

People needed

3

Starts

2009-03-01

Expected to finish

2009-10-01

Last updated by the study team

2014-01-07

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children with congenital heart disease requiring cardiopulmonary bypass(CPB) surgery less than 1 year of age admitted to the cardiac intensive care unit (CICU) preoperatively, who required blood sampling as part of their care.
• Subject must have arterial or central venous lines to be enrolled.
• Subject must have a documented weight of 2.5 Kilograms or greater.
• Subjects' legal guardian shall possess the ability to understand the purposes and risks of the study and provide an informed consent signature.

You may not qualify if…

• Medical urgency preventing timely administration of the consenting process.
• Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating. Specific conditions might include, but are not limited to, anemia or coagulopathy.
• Have given steroids intravenously (IV) or oral steroids within the last month.
• Have a preexisting neuroendocrine disorder.
• Have been treated with antipsychotic medication.
• Have human immunodeficiency virus (HIV).
• Have received etomidate for intubation.
• Other technical considerations that would prevent acquisition of sufficient samples OR inability / unwillingness of the legal guardian to provide consent.

Where it is running

• Children's Healthcare of Atlanta at Egleston — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.