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.
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 26, 2012
CompletedFirst Posted
Study publicly available on registry
June 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMarch 5, 2014
March 1, 2014
1.9 years
June 26, 2012
March 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All cause mortality
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary Outcomes (4)
Length of time in intensive care
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Ventilation days
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Use of vasopressors
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Thyroid hormones levels
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Study Arms (2)
Levothyroxine
EXPERIMENTAL3 mcg/kg/day
Control
PLACEBO COMPARATORCalcium magnesia.
Interventions
Eligibility Criteria
You may qualify if:
- All children aged 1 month to 17 years.
- Admitted to pediatric intensive care unit.
- TSH and thyroid hormones below age specific levels.
You may not qualify if:
- Known thyroid condition.
- Brain death.
- Gut conditions that contraindicate oral route.
- Readmissions to intensive care unit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sinaloa Pediatric Hospital
Culiacán, Sinaloa, 80200, Mexico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jesus J Martinez, MD
Sinaloa Pediatric Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
June 26, 2012
First Posted
June 29, 2012
Study Start
January 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
March 5, 2014
Record last verified: 2014-03