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Completed

NCT Number: NCT00027417

Study of Triostat in Infants During Heart Surgery

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.

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Key information

Conditions

Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocardial Cushion Defects Heart Diseases Heart Septal Defects Hypoplastic Left Heart Syndrome

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children's Hospital and Regional Medical Center

Seattle, Washington, 98105, United States

About this study

Patients will be randomized to receive study drug or placebo and randomization will occur stratified to each diagnostic category. All patients undergo preoperative echocardiograms to provide preoperative cardiac function data. The study drug or placebo will be provided in the operating room as an iv bolus just prior to cardiopulmonary bypass and as a bolus delivered on release of the aortic cross-clamp. This will be followed by iv for 12 hours. Operative data will be collected including CPB time, aortic cross-clamp time, length and degree of hypothermia. These data will be extracted from the anesthesia record.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Diagnosis of one of the following:

  • Ventricular septal defect (VSD)
  • Infant coarctation of the aorta
  • Transposition of the great arteries
  • Tetralogy of Fallot
  • Complete atrioventricular canal defect
  • Hypoplastic left heart, including patients who undergo a Norwood type procedure for aortic or mitral atresia

Patient must be scheduled for surgery.

Exclusion criteria

  • Certain additional defects and/or requirement for additional surgery.

Treatment and study plan

Liothyronine sodium/triiodothyronine

Drug

Cardiopulmonary bypass and cardiac surgery

Procedure

Primary outcomes

  1. duration of mechanical ventilation after cardiopulmonary bypass.

    Time frame: 0 to 72 hours

    Reducing the length of ventilatory support minimizes other postoperative complications, which can contribute to morbidity.

Secondary outcomes

  1. Assess other parameters

    Time frame: 0 to 72 hrs

    • Need for mechanic circulatory support, fluid balance (intake and output); urine output
    • Echocardiographic measures to include end-systolic wall stress/fractional shortening ratio
    • Myocardial performance index (Doppler derived), cardiac index (Doppler derived)
    • Heart rate, blood pressure and central venous pressure
    • Free and total T3 levels
    • Others: All medications including inotropic agents will be recorded with respect to time initiated, terminated, and dosage will be recorded for exploratory analyses.

Sponsors and collaborators

Lead sponsor

Michael Portman

Other

Registry information

Official study title

Triostat in Children During CardioPulmonary Bypass (CPB)

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Dec 7, 2001
Registry last updated
Aug 5, 2013

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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