Thyroid Hormones in Critically Ill Children

Official Title: “Thyroid Hormone Deficiency 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.

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • Patients who are receiving vasoactive medications and/or are mechanically ventilated.

Primary Measures

• 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.
    Safety Issue?: No

Secondary Measures

• 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.
    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
    Safety Issue?: No

Inclusion Criteria:

• Informed Consent
• Age of less than 12 months and less than or equal to 18
• Patient must weigh greater than 10 kgs.
• Patients must require vasoactive infusions and/or mechanical ventilation.
• Patients must be enrolled within 24 hours of meeting eligibility.

Exclusion Criteria:

• Patient with known or presumed pre-existing thyroid disease will be excluded
• Patients who receive thyroid supplementation will be excluded
• Patients with known or presumed hypothalamic and/or pituitary dysfunction that have thyroid hormone concentration abnormalities not related to an acute illness.
• Patients who are intubated for airway protection only.
• Patients intubated for neuromuscular disease
• Pregnant patients.
• Patients receiving amiodarone supplementation
• Patients who received blood product transfusions equaling more than 1/2 of their blood volume.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Months

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Children's Hospital of Philadelphia Other

Overall Clinical Trial Officials and Contacts

Athena Zuppa, MD, MSCE Principal Investigator Children's Hospital of Philadelphia  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00664079

Study ID Number: 2005-10-4547

ClinicalTrials.gov Identifier: NCT00664079

Health Authority: United States: Institutional Review Board