Thyroid Hormones in Critically Ill Children

NCT ID: NCT00664079

Last Updated: 2015-03-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2008-12-31

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.

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.

Conditions

Hypotension; Respiratory Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

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

Blood draws

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Critically Ill Children; Vasoactive Infusions in Children; Mechanical Venilation in Children; Thyroid Deficiency

Eligibility 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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Athena Zuppa, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

2005-10-4547

Identifier Type: -

Identifier Source: org_study_id