Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00207896
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2005-09-13
Brief Title:
Neuroendocrine Dysfunction in Critically Ill Pediatric Patients
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Defining the Prevalence of Acute Neuroendocrine Dysfunction and Correlating the Dysfunction With Outcomes in Critically Ill Pediatric Patients A Pilot Study
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None