Thyroid Hormones in Critically Ill Children

Respiratory Failure Clinical Trial

— Thyroid  

Official title:

Thyroid Hormone Deficiency in Critically Ill Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00664079
• Other study ID #: 2005-10-4547
• Status: Terminated
• Phase: N/A
• First received: April 18, 2008
• Last updated: March 11, 2015
• Start date: October 2005
• Est. completion date: December 2008

Study information

• Verified date: July 2008
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 18 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Hypotension
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia,	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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	No