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

NCT00850720 | Terminated Results

• 1 other identifier: IRB00007443
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

Biological Response Modifiers; Bypass Surgery; Cardiology; Congenital Heart Disease; Endocrinology; Hormone Dysfunction; Hormones; Neuroendocrinology; Pediatric Surgery

Outcome Measures

Primary Outcomes (1)

• NO Outcomes - Study Terminated Without Data.

  Study terminated - no data.

Study Arms (1)

Cardiac Surgery

Infants with congenital defects.

Other: Blood draws

Interventions

Blood draws OTHER

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

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

Cardiac Surgery

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients at Childrens Healthcare of Atlanta at Egleston

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• Children's Healthcare of Atlanta: collaborator

Study Sites (1)

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Blood Specimen Collection; Hydrocortisone; Arginine Vasopressin; Thyrotropin

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Pituitary Hormones, Anterior

Limitations and Caveats

Early termination of study; Technical problems with measurement leading to unreliable or uninterpretable data.

Results Point of Contact

• Title: Kiran Hebbar, MBBS
• Organization: Children's Healthcare of Atlanta

kiran.hebbar@choa.org

404-785-1600

Study Officials

• Kiran Hebbar, MBBS

  Emory University & Children's Healthcare of Atlanta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - CT

Study Record Dates

• First Submitted: February 24, 2009
• First Posted: February 25, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 7, 2014
• Results First Posted: January 7, 2014

Record last verified: 2013-11

Locations

US (1)