Thyroid Hormones in Critically Ill Children

This study has been terminated.
(Sluggish enrollment.)
Sponsor:
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00664079
First received: April 18, 2008
Last updated: July 14, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention
Hypotension
Respiratory Failure
Other: Blood draws

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thyroid Hormone Deficiency in Critically Ill Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome 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. ] [ Designated as safety issue: No ]

Secondary Outcome 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. ] [ 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


Enrollment: 22
Study Start Date: October 2005
Estimated Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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.
Other Names:
  • Critically Ill Children
  • Vasoactive Infusions in Children
  • Mechanical Venilation in Children
  • Thyroid Deficiency

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who are admitted to the Pediatric Intensive Care Unit at the Children's Hospital of Philadelphia will be approached if they meet inclusion criteria.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664079

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia,, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Athena Zuppa, MD, MSCE Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Athena Zuppa, MD, The Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00664079     History of Changes
Other Study ID Numbers: 2005-10-4547
Study First Received: April 18, 2008
Last Updated: July 14, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Thyroid Deficiency
Thyroid Stimulating Hormone

Additional relevant MeSH terms:
Critical Illness
Hypotension
Respiratory Insufficiency
Disease Attributes
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014