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Levothyroxine for Children With Euthyroid Sick Syndrome

Primary Purpose

Euthyroid Sick Syndrome

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Levothyroxine
Calcium magnesia
Sponsored by
Sinaloa Pediatric Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Euthyroid Sick Syndrome focused on measuring Euthyroid Sick Syndromes, Thyroxine, Intensive care

Eligibility Criteria

1 Month - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sinaloa Pediatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Levothyroxine

Control

Arm Description

3 mcg/kg/day

Calcium magnesia.

Outcomes

Primary Outcome Measures

All cause mortality

Secondary Outcome Measures

Length of time in intensive care
Ventilation days
Use of vasopressors
Thyroid hormones levels

Full Information

First Posted
June 26, 2012
Last Updated
March 4, 2014
Sponsor
Sinaloa Pediatric Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01631305
Brief Title
Levothyroxine for Children With Euthyroid Sick Syndrome
Official Title
Efficacy and Safety of Levothyroxine in Critical Children With Euthyroid Sick Syndrome in a Pediatric Intensive Care Unit.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sinaloa Pediatric Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Euthyroid Sick Syndrome
Keywords
Euthyroid Sick Syndromes, Thyroxine, Intensive care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Levothyroxine
Arm Type
Experimental
Arm Description
3 mcg/kg/day
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Calcium magnesia.
Intervention Type
Drug
Intervention Name(s)
Levothyroxine
Other Intervention Name(s)
Brand: Eutirox.
Intervention Description
3 mcg/kg/day
Intervention Type
Other
Intervention Name(s)
Calcium magnesia
Intervention Description
Placebo.
Primary Outcome Measure Information:
Title
All cause mortality
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary Outcome Measure Information:
Title
Length of time in intensive care
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Title
Ventilation days
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Title
Use of vasopressors
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Title
Thyroid hormones levels
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesus J Martinez, MD
Organizational Affiliation
Sinaloa Pediatric Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sinaloa Pediatric Hospital
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80200
Country
Mexico

12. IPD Sharing Statement

Links:
URL
http://hospitalpediatrico.org/
Description
Sinaloa Pediatric Hospital

Learn more about this trial

Levothyroxine for Children With Euthyroid Sick Syndrome

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