Clinical Trial: Study of Triostat in Infants During Heart Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Triostat in Children During CardioPulmonary Bypass (CPB)

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Michael Portman

Current Primary Outcome: 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.


Original Primary Outcome:

Current Secondary Outcome: 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.


Original Secondary Outcome:

Information By: Seattle Children's Hospital

Dates:
Date Received: December 5, 2001
Date Started: April 2001
Date Completion:
Last Updated: August 1, 2013
Last Verified: August 2013