Levothyroxine for Children With Euthyroid Sick Syndrome

Sinaloa Pediatric Hospital

Status and phase: Completed; Phase 4

Conditions: Euthyroid Sick Syndrome

Treatments: Drug: Levothyroxine; Other: Calcium magnesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01631305

HPS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 1 month to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups, including a placebo group

Levothyroxine

Experimental group

Description:

3 mcg/kg/day

Treatment:

Drug: Levothyroxine

Control

Placebo Comparator group

Description:

Calcium magnesia.

Treatment:

Other: Calcium magnesia