Levothyroxine for Children With Euthyroid Sick Syndrome | NCT01631305

Studies
Levothyroxine for Children With Euthyroid Sick Syndrome

NCT01631305

Sponsor

Sinaloa Pediatric Hospital

Status

Completed

Last Update Posted

Mar 5, 2014Estimated

Enrollment

80Estimated

Phase

Phase 4

Conditions

Euthyroid Sick Syndrome

Interventions

Levothyroxine
Calcium magnesia

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jun 26, 2012

First Submission Date that Met QC Criteria

Jun 27, 2012

First Posted Date

Jun 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2014

Last Update Posted Date

Mar 5, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jesús Javier Martínez-García, Principal investigator, Sinaloa Pediatric HospitalPrincipal Investigator

Lead Sponsor

Sinaloa Pediatric HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Levothyroxine	Experimental	3 mcg/kg/day	Drug: Levothyroxine
Control	Placebo Comparator	Calcium magnesia.	Other: Calcium magnesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levothyroxine	Drug	3 mcg/kg/day	Levothyroxine	Brand: Eutirox.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jesus J Martinez, MD	Sinaloa Pediatric Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sinaloa Pediatric Hospital		Culiacán	Sinaloa	80200	Mexico

Label	URL
Sinaloa Pediatric Hospital	View source

Condition Browse Module

MeSH Terms

ID	Term
D005067	Euthyroid Sick Syndromes

Ancestor Terms

ID	Term
D013959	Thyroid Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013974	Thyroxine

Ancestor Terms

ID	Term
D013963	Thyroid Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D024322	Amino Acids, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided