Study of Triostat in Infants During Heart Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Portman, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT00027417
First received: December 5, 2001
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Triostat in Children During CardioPulmonary Bypass (CPB)

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • duration of mechanical ventilation after cardiopulmonary bypass. [ Time Frame: 0 to 72 hours ] [ Designated as safety issue: Yes ]
    Reducing the length of ventilatory support minimizes other postoperative complications, which can contribute to morbidity.


Secondary Outcome Measures:
  • Assess other parameters [ Time Frame: 0 to 72 hrs ] [ Designated as safety issue: Yes ]
    • 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.


Enrollment: 195
Study Start Date: April 2001
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Seattle Children's Hospital

Additional 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
Study First Received: December 5, 2001
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on October 01, 2014