Levothyroxine for Children With Euthyroid Sick Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jesús Javier Martínez-García, Sinaloa Pediatric Hospital
ClinicalTrials.gov Identifier:
NCT01631305
First received: June 26, 2012
Last updated: March 4, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Ventilation days [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
  • Use of vasopressors [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ] [ Designated as safety issue: No ]
  • Thyroid hormones levels [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   1 Month to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Jesús Javier Martínez-García, Principal investigator, Sinaloa Pediatric Hospital
ClinicalTrials.gov Identifier: NCT01631305     History of Changes
Other Study ID Numbers: HPS-01
Study First Received: June 26, 2012
Last Updated: March 4, 2014
Health Authority: Mexico: Secretaria de Salud

Keywords provided by Sinaloa Pediatric Hospital:
Euthyroid Sick Syndromes
Thyroxine
Intensive care

Additional relevant MeSH terms:
Euthyroid Sick Syndromes
Thyroid Diseases
Endocrine System Diseases
Magnesium Oxide
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014