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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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01631305
Enrollment
80
Registered
2012-06-29
Start date
2012-01-31
Completion date
2013-12-31
Last updated
2014-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Euthyroid Sick Syndrome

Keywords

Euthyroid Sick Syndromes, Thyroxine, Intensive care

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.

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.

Interventions

DRUGLevothyroxine

3 mcg/kg/day

OTHERCalcium magnesia

Placebo.

Sponsors

Sinaloa Pediatric Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Months to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
All cause mortalityparticipants will be followed for the duration of hospital stay, an expected average of 3 weeks

Secondary

MeasureTime frame
Length of time in intensive careparticipants will be followed for the duration of hospital stay, an expected average of 2 weeks
Ventilation daysparticipants will be followed for the duration of hospital stay, an expected average of 2 weeks
Use of vasopressorsparticipants will be followed for the duration of hospital stay, an expected average of 3 weeks
Thyroid hormones levelsparticipants will be followed for the duration of hospital stay, an expected average of 3 weeks

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026