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Study of Triostat in Infants During Heart Surgery

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ClinicalTrials.gov Identifier: NCT00027417
Recruitment Status : Completed
First Posted : December 7, 2001
Last Update Posted : August 5, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Heart Defects, Congenital Drug: Liothyronine sodium/triiodothyronine Procedure: Cardiopulmonary bypass and cardiac surgery Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Triostat in Children During CardioPulmonary Bypass (CPB)
Study Start Date : April 2001
Primary Completion Date : August 2007
Study Completion Date : August 2007


Arms and Interventions

Arm Intervention/treatment
Active Comparator: Liothyronine Sodium/Triiodothyronine
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
Placebo Comparator: Placebo
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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00027417


Locations
United States, Washington
Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Michael Portman
Investigators
Principal Investigator: Michael Portman, MD Seattle Childrens Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Portman, Cardiologist, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT00027417     History of Changes
Other Study ID Numbers: FD-R-1971-01
FD-R-001971-01
First Posted: December 7, 2001    Key Record Dates
Last Update Posted: August 5, 2013
Last Verified: August 2013

Keywords provided by Michael Portman, Seattle Children's Hospital:
Congenital heart defects
Hypoplastic left heart syndrome
Complete atrioventricular canal defect
Triostat
Cardiac surgery

Additional relevant MeSH terms:
Congenital Abnormalities
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases