Levothyroxine for Children With Euthyroid Sick Syndrome

Euthyroid Sick Syndrome Clinical Trial

Official title:

Efficacy and Safety of Levothyroxine in Critical Children With Euthyroid Sick Syndrome in a Pediatric Intensive Care Unit.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631305
• Other study ID #: HPS-01
• Status: Completed
• Phase: Phase 4
• First received: June 26, 2012
• Last updated: March 4, 2014
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Sinaloa Pediatric Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether levothyroxine is effective and safe in the treatment of children with euthyroid sick syndrome, hospitalized in a pediatric intensive care unit.

Description:

Children with euthyroid sick syndrome, hospitalized in a pediatric intensive care unit, will be randomised to receive either Levothyroxine or placebo, to determine if it diminishes mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 17 Years

Eligibility

Inclusion Criteria:

• All children aged 1 month to 17 years.

• Admitted to pediatric intensive care unit.

• TSH and thyroid hormones below age specific levels.

Exclusion Criteria:

• Known thyroid condition.

• Brain death.

• Gut conditions that contraindicate oral route.

• Readmissions to intensive care unit.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Euthyroid Sick Syndrome
• Euthyroid Sick Syndromes
• Syndrome

Intervention

Drug:
• Levothyroxine
3 mcg/kg/day

Other:
• Calcium magnesia
Placebo.

Locations

Country	Name	City	State
Mexico	Sinaloa Pediatric Hospital	Culiacan	Sinaloa

Sponsors (1)

Lead Sponsor	Collaborator
Sinaloa Pediatric Hospital

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		participants will be followed for the duration of hospital stay, an expected average of 3 weeks	No
Secondary	Length of time in intensive care		participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No
Secondary	Ventilation days		participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No
Secondary	Use of vasopressors		participants will be followed for the duration of hospital stay, an expected average of 3 weeks	No
Secondary	Thyroid hormones levels		participants will be followed for the duration of hospital stay, an expected average of 3 weeks	No

External Links

•   Sinaloa Pediatric Hospital