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OpenTrials
Completed

NCT Number: NCT02320669

Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery. Funding Source - FDA OOPD.

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Key information

Conditions

Congenital Heart Defects Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

Up to 5 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Los Angeles Children's Hospital, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent obtained
  • Male and female patients <5 months (152 days) of age
  • Patients undergoing cardiopulmonary bypass

Exclusion criteria

  • Known thyroid disease (Down Syndrome is not an exclusion criterion unless patient has thyroid disease)
  • Trisomy 13 and 18
  • Prolonged preoperative ventilator support which would not be impacted by cardiac surgery (Lung disease: bronchopulmonary dysplasia, hypoplastic lungs associated with diaphragmatic hernia)
  • Any other condition as determined by the PI causing prolonged ventilator support which is unlikely to respond favorably to cardiac surgery
  • Prior participation in the clinical trial

Treatment and study plan

Triostat

Drug

Bolus of Triiodothyronine followed by infusion for 48 hours

Other names: triiodothyronine

Placebo

Drug

Bolus of Placebo followed by infusion for 48 hours

Primary outcomes

  1. Time To Extubation

    Time frame: 30 days

    time on mechanical ventilation after aortic cross clamp removal

Secondary outcomes

  1. ICU Length of Stay

    Time frame: 30 days

    Length of stay in the ICU

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Registry information

Acronym: TRICC-2

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2014
Registry last updated
Apr 9, 2024

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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