Levothyroxine for Children With Euthyroid Sick Syndrome

March 4, 2014 updated by: Jesús Javier Martínez-García, Sinaloa Pediatric Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80200
        • Sinaloa Pediatric Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levothyroxine
3 mcg/kg/day
Drug: Levothyroxine
3 mcg/kg/day
Other Names:
  • Brand: Eutirox.
Placebo Comparator: Control
Calcium magnesia.
Other: Calcium magnesia
Placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinaloa Pediatric Hospital

Investigators

  • Study Chair: Jesus J Martinez, MD, Sinaloa Pediatric Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 26, 2012

First Submitted That Met QC Criteria

June 27, 2012

First Posted (Estimate)

June 29, 2012

Study Record Updates

Last Update Posted (Estimate)

March 5, 2014

Last Update Submitted That Met QC Criteria

March 4, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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