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

November 18, 2013 updated by: Kiran Hebbar, Emory University

Prevalence of Neuroendocrine Dysfunction in the Pediatric Cardiopulmonary Bypass Patient

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta at Egleston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients at Childrens Healthcare of Atlanta at Egleston

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
NO Outcomes - Study Terminated Without Data.
Time Frame: Study terminated - no data.
Study terminated - no data.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

Children's Healthcare of Atlanta

Investigators

  • Principal Investigator: Kiran Hebbar, MBBS, Emory University & Children's Healthcare of Atlanta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

February 24, 2009

First Submitted That Met QC Criteria

February 24, 2009

First Posted (Estimate)

February 25, 2009

Study Record Updates

Last Update Posted (Estimate)

January 7, 2014

Last Update Submitted That Met QC Criteria

November 18, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00007443

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congenital Heart Disease

Clinical Trials on Blood draws

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe