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Levothyroxine for Children With Euthyroid Sick Syndrome

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ClinicalTrials.gov Identifier: NCT01631305
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : March 5, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Euthyroid Sick Syndrome Drug: Levothyroxine Other: Calcium magnesia Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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.
Study Start Date : January 2012
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

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

Secondary Outcome Measures :
  1. Length of time in intensive care [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
  2. Ventilation days [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
  3. Use of vasopressors [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]
  4. Thyroid hormones levels [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]

Eligibility Criteria

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 Posted: June 29, 2012    Key Record Dates
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