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Completed

NCT Number: NCT01631305

Levothyroxine for Children With Euthyroid Sick Syndrome

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.

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Key information

Conditions

Euthyroid Sick Syndrome Endocrine System Diseases Euthyroid Sick Syndromes Thyroid Diseases

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sinaloa Pediatric Hospital

Culiacán, Sinaloa, 80200, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levothyroxine

Drug

3 mcg/kg/day

Other names: Brand: Eutirox.

Calcium magnesia

Other

Placebo.

Primary outcomes

  1. All cause mortality

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Secondary outcomes

  1. Length of time in intensive care

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  2. Ventilation days

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  3. Use of vasopressors

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  4. Thyroid hormones levels

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Sponsors and collaborators

Lead sponsor

Sinaloa Pediatric Hospital

Other

Registry information

Official study title

Efficacy and Safety of Levothyroxine in Critical Children With Euthyroid Sick Syndrome in a Pediatric Intensive Care Unit.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 29, 2012
Registry last updated
Mar 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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