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

Congenital Heart Disease Clinical Trial

Official title:

Prevalence of Neuroendocrine Dysfunction in the Pediatric Cardiopulmonary Bypass Patient

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00850720
• Other study ID #: IRB00007443
• Status: Terminated
• Phase: N/A
• First received: February 24, 2009
• Last updated: November 18, 2013
• Start date: March 2009
• Est. completion date: October 2009

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• Blood draws
Samples of blood to be drawn before surgery, and nine hours after surgery.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta at Egleston	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NO Outcomes - Study Terminated Without Data.		Study terminated - no data.	No