Levothyroxine for Children With Euthyroid Sick Syndrome

Phase 4

Completed

• Conditions: Euthyroid Sick Syndrome
• Interventions: Other: Calcium magnesia; Drug: Levothyroxine

• Registration Number: NCT01631305
• Lead Sponsor: Sinaloa Pediatric Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-27
• Study First Posted: 2012-06-29
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-04
• Last Update Posted: 2014-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• All children aged 1 month to 17 years.
• Admitted to pediatric intensive care unit.
• TSH and thyroid hormones below age specific levels.

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Exclusion Criteria

• Known thyroid condition.
• Brain death.
• Gut conditions that contraindicate oral route.
• Readmissions to intensive care unit.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Calcium magnesia	Calcium magnesia.
Levothyroxine	Levothyroxine	3 mcg/kg/day

Primary Outcome Measures

Name	Time	Method
All cause mortality	participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Secondary Outcome Measures

Name	Time	Method
Thyroid hormones levels	participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Use of vasopressors	participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Length of time in intensive care	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Ventilation days	participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Trial Locations

Locations (1)

Sinaloa Pediatric Hospital; 🇲🇽 Culiacan, Sinaloa, Mexico