Study of Triostat in Infants During Heart Surgery

August 1, 2013 updated by: Michael Portman

Triostat in Children During CardioPulmonary Bypass (CPB)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

195

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 to 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 to 72 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Portman

Investigators

  • Principal Investigator: Michael Portman, MD, Seattle Childrens Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

December 5, 2001

First Submitted That Met QC Criteria

December 6, 2001

First Posted (Estimate)

December 7, 2001

Study Record Updates

Last Update Posted (Estimate)

August 5, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FD-R-1971-01
  • FD-R-001971-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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