Thyroid Hormones in Critically Ill Children (Thyroid)

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.

Study Overview

• Status: Terminated
• Conditions: Respiratory Failure; Hypotension
• Intervention / Treatment: Other: Blood draws

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.

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia,, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Athena Zuppa, MD, MSCE, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: April 18, 2008
• First Submitted That Met QC Criteria: April 18, 2008
• First Posted (Estimate): April 22, 2008

Study Record Updates

• Last Update Posted (Estimate): March 12, 2015
• Last Update Submitted That Met QC Criteria: March 11, 2015
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Thyroid Deficiency; Thyroid Stimulating Hormone
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Hypotension
• Other Study ID Numbers: 2005-10-4547

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No