Levothyroxine for Children With Euthyroid Sick Syndrome

NCT ID: NCT01631305

Last Updated: 2014-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Euthyroid Sick Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Levothyroxine

3 mcg/kg/day

Group Type EXPERIMENTAL

Levothyroxine

Intervention Type DRUG

3 mcg/kg/day

Control

Calcium magnesia.

Group Type PLACEBO_COMPARATOR

Calcium magnesia

Intervention Type OTHER

Placebo.

Interventions

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Levothyroxine

3 mcg/kg/day

Intervention Type DRUG

Calcium magnesia

Placebo.

Intervention Type OTHER

Other Intervention Names

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Brand: Eutirox.

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sinaloa Pediatric Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jesús Javier Martínez-García

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jesus J Martinez, MD

Role: STUDY_CHAIR

Sinaloa Pediatric Hospital

Locations

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Sinaloa Pediatric Hospital

Culiacán, Sinaloa, Mexico

Site Status

Countries

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Mexico

Related Links

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http://hospitalpediatrico.org/

Sinaloa Pediatric Hospital

Other Identifiers

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HPS-01

Identifier Type: -

Identifier Source: org_study_id

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