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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac Surgery

Infants with congenital defects.

Blood draws

Intervention Type OTHER

Samples of blood to be drawn before surgery, and nine hours after surgery.

Interventions

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Blood draws

Samples of blood to be drawn before surgery, and nine hours after surgery.

Intervention Type OTHER

Other Intervention Names

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Tests being analyzed: • Cortisol • Vasopressin (ADH) • Cortisol Free • Thyroid Stimulating Hormone (TSH) • Free Thyroxine(FT4)

Eligibility Criteria

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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.

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No