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Levothyroxine for Children With Euthyroid Sick Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01631305
First Posted: June 29, 2012
Last Update Posted: March 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jesús Javier Martínez-García, Sinaloa Pediatric Hospital
June 26, 2012
June 29, 2012
March 5, 2014
January 2012
December 2013   (Final data collection date for primary outcome measure)
All cause mortality [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]
Same as current
Complete list of historical versions of study NCT01631305 on ClinicalTrials.gov Archive Site
  • Length of time in intensive care [ Time Frame: 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 ]
  • Use of vasopressors [ Time Frame: 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 ]
Same as current
Not Provided
Not Provided
 
Levothyroxine for Children With Euthyroid Sick Syndrome
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Euthyroid Sick Syndrome
  • Drug: Levothyroxine
    3 mcg/kg/day
    Other Name: Brand: Eutirox.
  • Other: Calcium magnesia
    Placebo.
  • Experimental: Levothyroxine
    3 mcg/kg/day
    Intervention: Drug: Levothyroxine
  • Placebo Comparator: Control
    Calcium magnesia.
    Intervention: Other: Calcium magnesia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2013
December 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
1 Month to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT01631305
HPS-01
No
Not Provided
Not Provided
Jesús Javier Martínez-García, Sinaloa Pediatric Hospital
Sinaloa Pediatric Hospital
Not Provided
Study Chair: Jesus J Martinez, MD Sinaloa Pediatric Hospital
Sinaloa Pediatric Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP