Study of Triostat in Infants During Heart Surgery

Heart Defects, Congenital Clinical Trial

Official title:

Triostat in Children During CardioPulmonary Bypass (CPB)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00027417
• Other study ID #: FD-R-1971-01
• Secondary ID: FD-R-001971-01
• Status: Completed
• Phase: Phase 3
• First received: December 5, 2001
• Last updated: August 1, 2013
• Start date: April 2001
• Est. completion date: August 2007

Study information

• Verified date: August 2013
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Intervention

Drug:
• Liothyronine sodium/triiodothyronine

Procedure:
• Cardiopulmonary bypass and cardiac surgery

Locations

Country	Name	City	State
United States	Children's Hospital and Regional Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Michael Portman

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of mechanical ventilation after cardiopulmonary bypass.	Reducing the length of ventilatory support minimizes other postoperative complications, which can contribute to morbidity.	0 to 72 hours	Yes
Secondary	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.	0 to 72 hrs	Yes