Thyroid Hormones in Critically Ill Children - Full Text View

Sponsored by:	Children's Hospital of Philadelphia
Information provided by:	Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT00664079

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

MedlinePlus related topics: Low Blood Pressure

Drug Information available for: Thyroid hormones Thyroid

U.S. FDA Resources

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

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

Biospecimen Description:

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.

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

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

Keywords provided by Children's Hospital of Philadelphia:

Thyroid Deficiency
Thyroid Stimulating Hormone

Study placed in the following topic categories:

Hypotension
Respiratory Insufficiency
Respiratory Tract Diseases
Critical Illness
Hormone Antagonists

Respiration Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Vascular Diseases
Hormones

Additional relevant MeSH terms:

Hypotension
Disease Attributes
Respiration Disorders
Physiological Effects of Drugs
Vascular Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones

Pharmacologic Actions
Respiratory Insufficiency
Pathologic Processes
Respiratory Tract Diseases
Critical Illness
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009