Thyroid Hormones in Critically Ill Children
Thyroid hormones are substances naturally made by the body and are important to many of your body's basic functions such as breathing and brain function. We are investigating whether or not these hormones are at lower levels in critically ill children which could lead to further health problems. We hope to get a better understanding of hormone levels and their effects on critically ill children to better help other children in the future.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Thyroid Hormone Deficiency in Critically Ill Children|
- Certain critically ill children requiring vasoactive infusions and/or mechanical ventilation have low concentrations of tT3, fT3, tT4, fT4, elevated rT3, adn inappropriate low/normal TSH. [ Time Frame: When patient has completed the study. ] [ Designated as safety issue: No ]
- Critically ill children with more severe thyroid hormone deficiencies will have greater severity of illness, intensity of therapeutic intervention, organ dysfunction, and increased morbidity and mortality. [ Time Frame: When study is completed. ] [ Designated as safety issue: No ]
- Critically ill children requiring vasoactive infusions and/or mechanical ventilation are a population in the ICU that has thyroid hormone pertubation and significant morbidity and mortality. [ Time Frame: At completion of study ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Whole blood and serum
|Study Start Date:||October 2005|
|Estimated Study Completion Date:||December 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Patients who are receiving vasoactive medications and/or are mechanically ventilated.
Other: Blood draws
17 mls of blood will be drawn over a 5 day period from either a central venous catheter/arterial line or with scheduled phlebotomy. The following labs will be run tT3, fT3, rT#, tT4, fT4, TSH, and tyrosine.
We hypothesize that critically ill children that require vasoactive infusions and/or invasive mechanical ventilation have thyroid hormone alterations. We will measure TSH, tT3, fT3, rT3, tT4, fT4, adn tyrosine concentrations in critically ill children with hypotension and/or respiratory failure and correlate thyroid hormone alterations to severity of illness, intensity of therapeutic interventions, and associated morbidity and mortality by using clinical outcomes parameters.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00664079
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia,, Pennsylvania, United States, 19104|
|Principal Investigator:||Athena Zuppa, MD, MSCE||Children's Hospital of Philadelphia|