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Levothyroxine for Children With Euthyroid Sick Syndrome

Information source: Sinaloa Pediatric Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Euthyroid Sick Syndrome

Intervention: Levothyroxine (Drug); Calcium magnesia (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Sinaloa Pediatric Hospital

Official(s) and/or principal investigator(s):
Jesus J Martinez, MD, Study Chair, Affiliation: Sinaloa Pediatric Hospital

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.

Clinical Details

Official title: Efficacy and Safety of Levothyroxine in Critical Children With Euthyroid Sick Syndrome in a Pediatric 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

Primary outcome: All cause mortality

Secondary outcome:

Length of time in intensive care

Ventilation days

Use of vasopressors

Thyroid hormones levels

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.

Eligibility

Minimum age: 1 Month. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Sinaloa Pediatric Hospital, Culiacan, Sinaloa 80200, Mexico
Additional Information

Sinaloa Pediatric Hospital

Starting date: January 2012
Last updated: March 4, 2014

Page last updated: August 23, 2015

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