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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Syndrome
Disease
Endocrine System Diseases
Pathologic Processes
Thyroid Diseases

ClinicalTrials.gov processed this record on November 23, 2014