Study of Possible Brain Hormone Problems After Open Heart Surgery in Infants
Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Congenital Heart Disease
Intervention: Blood draws (Other)
Phase: N/A
Status: Terminated
Sponsored by: Emory University Official(s) and/or principal investigator(s): Kiran Hebbar, MBBS, Principal Investigator, Affiliation: Emory University & Children's Healthcare of Atlanta
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.
Clinical Details
Official title: Prevalence of Neuroendocrine Dysfunction in the Pediatric Cardiopulmonary Bypass Patient
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: NO Outcomes - Study Terminated Without Data.
Eligibility
Minimum age: N/A.
Maximum age: 1 Year.
Gender(s): Both.
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.
Locations and Contacts
Children's Healthcare of Atlanta at Egleston, Atlanta, Georgia 30322, United States
Additional Information
Starting date: March 2009
Last updated: November 18, 2013
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