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Study of Triostat in Infants During Heart Surgery

Information source: Seattle Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Defects, Congenital

Intervention: Liothyronine sodium/triiodothyronine (Drug); Cardiopulmonary bypass and cardiac surgery (Procedure)

Phase: Phase 3

Status: Completed

Sponsored by: Michael Portman

Official(s) and/or principal investigator(s):
Michael Portman, MD, Principal Investigator, Affiliation: Seattle Childrens Hospital

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.

Clinical Details

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

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

Primary outcome: duration of mechanical ventilation after cardiopulmonary bypass.

Secondary outcome: Assess other parameters

Detailed 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.

Eligibility

Minimum age: N/A. Maximum age: 2 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Children's Hospital and Regional Medical Center, Seattle, Washington 98105, United States
Additional Information

Starting date: April 2001
Last updated: August 1, 2013

Page last updated: August 23, 2015

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