Thyroid Hormones in Critically Ill Children

NCT00664079 | Terminated

• 1 other identifier: 2005-10-4547
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypotension; Respiratory Failure

Keywords

Thyroid Deficiency; Thyroid Stimulating Hormone

Outcome Measures

Primary Outcomes (1)

• 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.

  When patient has completed the study.

Secondary Outcomes (2)

• 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.

  When study is completed.

• 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.

  At completion of study

Study Arms (1)

1

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

Other: Blood draws

Interventions

Blood draws OTHER

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.

Also known as: Critically Ill Children, Vasoactive Infusions in Children, Mechanical Venilation in Children, Thyroid Deficiency

1

Eligibility Criteria

• Age: 12 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and serum

MeSH Terms

Conditions

Hypotension; Respiratory Insufficiency; Hypothyroidism

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Athena Zuppa, MD, MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 22, 2008
• Study Start: October 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 12, 2015

Record last verified: 2008-07

Locations

US (1)