Clinical trial NCT00850720: Study of Possible Brain Hormone Problems After Open Heart Surgery in Infants
Official title: Prevalence of Neuroendocrine Dysfunction in the Pediatric Cardiopulmonary Bypass Patient
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Heart Disease
Keywords: Biological Response Modifiers
Bypass Surgery
Cardiology
Congenital Heart Disease
Endocrinology
Hormone Dysfunction
Hormones
Neuroendocrinology
Pediatric Surgery
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Children's Healthcare of Atlanta
First posted: 2009-02-25
Enrollment: 3
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at Childrens Healthcare of Atlanta at Egleston

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: NO Outcomes - Study Terminated Without Data.
timeFrame: Study terminated - no data.
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Egleston
state: Georgia
Study officials:
affiliation: Emory University & Children's Healthcare of Atlanta
name: Kiran Hebbar, MBBS
role: PRINCIPAL_INVESTIGATOR
References: