Status:
TERMINATED
Study of Possible Brain Hormone Problems After Open Heart Surgery in Infants
Lead Sponsor:
Emory University
Collaborating Sponsors:
Children's Healthcare of Atlanta
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
Up to 1 years
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 provi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00850720
Start Date
March 1 2009
End Date
October 1 2009
Last Update
January 7 2014
Active Locations (1)
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1
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322