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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
  Purpose
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.

Condition Intervention Phase
Euthyroid Sick Syndrome Drug: Levothyroxine Other: Calcium magnesia Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Levothyroxine in Critical Children With Euthyroid Sick Syndrome in a Pediatric Intensive Care Unit.

Resource links provided by NLM:


Further study details as provided by Jesús Javier Martínez-García, Sinaloa Pediatric Hospital:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: January 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levothyroxine
3 mcg/kg/day
Drug: Levothyroxine
3 mcg/kg/day
Other Name: Brand: Eutirox.
Placebo Comparator: Control
Calcium magnesia.
Other: Calcium magnesia
Placebo.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631305


Locations
Mexico
Sinaloa Pediatric Hospital
Culiacan, Sinaloa, Mexico, 80200
Sponsors and Collaborators
Sinaloa Pediatric Hospital
Investigators
Study Chair: Jesus J Martinez, MD Sinaloa Pediatric Hospital
  More Information

Additional Information:
Responsible Party: Jesús Javier Martínez-García, Principal investigator, Sinaloa Pediatric Hospital
ClinicalTrials.gov Identifier: NCT01631305     History of Changes
Other Study ID Numbers: HPS-01
First Submitted: June 26, 2012
First Posted: June 29, 2012
Last Update Posted: March 5, 2014
Last Verified: March 2014

Keywords provided by Jesús Javier Martínez-García, Sinaloa Pediatric Hospital:
Euthyroid Sick Syndromes
Thyroxine
Intensive care

Additional relevant MeSH terms:
Syndrome
Euthyroid Sick Syndromes
Disease
Pathologic Processes
Thyroid Diseases
Endocrine System Diseases
Magnesium Oxide
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents