A Phase 3 interventional study of Liothyronine sodium/triiodothyronine and Cardiopulmonary bypass and cardiac surgery in Heart Defects, Congenital, sponsored by Michael Portman. Completed at 1 site in United States. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2013-08-05.
Sponsored by Michael Portman · Phase 3, Interventional, and Treatment
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.
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.
1,007 studies on the registry are indexed under Heart Defects, Congenital; 257 are open to participants now.
This study's enrollment of 195 is above the median of 60 across 524 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Michael Portman is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis of one of the following:
Patient must be scheduled for surgery.
Exclusion criteria:
bolus administration of Liothyronine Sodium/Triiodothyronine (Triostat) immediately prior to CPB institution and after removal of aortic cross clamp, followed by repeated boluses, will be safe and will result in significant improvements in postoperative and clinical outcome parameters and cardiac contractile function.
Drug: Liothyronine sodium/triiodothyronine · Procedure: Cardiopulmonary bypass and cardiac surgery
bolus administration of Placebo immediately prior to CPB institution and after removal of aortic cross clamp, followed by repeated boluses
Drug: Liothyronine sodium/triiodothyronine · Procedure: Cardiopulmonary bypass and cardiac surgery
duration of mechanical ventilation after cardiopulmonary bypass.
Reducing the length of ventilatory support minimizes other postoperative complications, which can contribute to morbidity.
Time frame: 0 to 72 hours
Assess other parameters
* 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.
Time frame: 0 to 72 hrs
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Michael Portman