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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00850720
Recruitment Status : Terminated (Inability to recruit / logistic problems.)
First Posted : February 25, 2009
Results First Posted : January 7, 2014
Last Update Posted : January 7, 2014
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
Kiran Hebbar, Emory University

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.

Condition or disease Intervention/treatment
Congenital Heart Disease Other: Blood draws

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Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence of Neuroendocrine Dysfunction in the Pediatric Cardiopulmonary Bypass Patient
Study Start Date : March 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Group/Cohort Intervention/treatment
Cardiac Surgery
Infants with congenital defects.
Other: Blood draws
Samples of blood to be drawn before surgery, and nine hours after surgery.
Other Names:
  • Tests being analyzed:
  • • Cortisol
  • • Vasopressin (ADH)
  • • Cortisol Free
  • • Thyroid Stimulating Hormone (TSH)
  • • Free Thyroxine(FT4)

Primary Outcome Measures :
  1. NO Outcomes - Study Terminated Without Data. [ Time Frame: Study terminated - no data. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at Childrens Healthcare of Atlanta at Egleston

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00850720

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United States, Georgia
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Children's Healthcare of Atlanta
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Principal Investigator: Kiran Hebbar, MBBS Emory University & Children's Healthcare of Atlanta

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Responsible Party: Kiran Hebbar, Assistant Professor - CT, Emory University Identifier: NCT00850720     History of Changes
Other Study ID Numbers: IRB00007443
First Posted: February 25, 2009    Key Record Dates
Results First Posted: January 7, 2014
Last Update Posted: January 7, 2014
Last Verified: November 2013
Keywords provided by Kiran Hebbar, Emory University:
Biological Response Modifiers
Bypass Surgery
Congenital Heart Disease
Hormone Dysfunction
Pediatric Surgery
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents