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Neuroendocrine Dysfunction in Critically Ill Pediatric Patients

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ClinicalTrials.gov Identifier: NCT00207896
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : December 2, 2014
Information provided by (Responsible Party):
Children's Healthcare of Atlanta

Brief Summary:
Research studies in adults have shown that certain hormones may be decreased or may not work normally which contributes to how sick a person becomes. The purpose of this project is to study hormones in children. The investigators will look to see if a decrease of certain hormone levels affects how sick a child may become. This study is intended to develop a connection between hormone levels and severity of illness. It is hoped that the information gathered will help develop further studies that may more clearly explain the role of hormones in critically ill children and possibly the introduction of hormone replacement in critical illness.

Condition or disease
Critical Illness

Detailed Description:

Neuroendocrine dysfunction is an abnormality in the production or release of certain hormones. Studies completed in adult patients have shown abnormal hormone levels in critical illness can contribute to how long patients stay in the intensive care unit, how severe their illness is and whether or not they survive. In children hormones are produced differently and have different functions. Depending on the particular illness in question hormonal dysfunction may have grave clinical consequences.

Thus far, there have been few studies that have examined neuroendocrine dysfunction in children. The aim of our study is to identify the common hormone responses in children, and to identify any connection between hormone levels and outcomes (likelihood of child staying in the intensive care unit for multiple days, etc.).

To explore these aims we will draw blood from all critically ill patients admitted to the pediatric intensive care unit (PICU) and check various hormone levels. Only those patients who require blood samples as part of their admission will have blood tests for certain hormone levels. No change will be made from established standard of care for a patient's particular critical illness.

The study is designed to examine hormone responses to critical illness and identify a connection between hormone levels and severity of illness. Based on these lab values we intend to lay a foundation for further studies that may more clearly explain the role of hormones in critically ill children, and possibly the introduction of hormone replacement in critical illness.

Study Type : Observational
Actual Enrollment : 73 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Defining the Prevalence of Acute Neuroendocrine Dysfunction and Correlating the Dysfunction With Outcomes in Critically Ill Pediatric Patients: A Pilot Study
Study Start Date : August 2004
Primary Completion Date : August 2007
Study Completion Date : August 2007

Primary Outcome Measures :
  1. To determine the prevalence of neuroendocrine dysfunction in critically ill pediatric patients. [ Time Frame: 13 months ]
    Conclued that neuroendocrine deficiency is present in critically ill pediatric patients. Prevalence is not greater in septic patients. Seventy-three children were enrolled over 13-month period. Larger scale studies are necessary to determine if presence of NEAD, or specific combinations of axis deficiency, is important in predicting outcomes or benefit of early hormonal replacement therapies in critically ill children.

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Ages Eligible for Study:   5 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients admitted to PICU

Inclusion Criteria:

  • All patients, birth - 18 years of age
  • Admitted to the pediatric intensive care unit requiring blood to be drawn as part of medical management consistent with "standard of care".

Exclusion Criteria:

  • Elective post-operative surgical patients.
  • Pre-existing/known neuroendocrine disorder including, but not limited to, disorders of the hypothalamus, pituitary, adrenal, or thyroid gland.
  • Patients being treated with or having a recent history of taking anti-psychotic medications (e.g. ingestion).
  • Patients whose laboratory specimens have already been drawn prior to admission (emergency room or another facility) and who do not require further blood draws for medical management within a 12 hour window.

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 ClinicalTrials.gov identifier (NCT number): NCT00207896

United States, Georgia
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Principal Investigator: James D Fortenberry, MD Children's Healthcare of Atlanta

Responsible Party: Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00207896     History of Changes
Other Study ID Numbers: 04-068
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by Children's Healthcare of Atlanta:
Pediatric Intensive Care
Neuroendocrine Dysfunction

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes