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Study of Triostat in Infants During Heart Surgery

NCT ID: NCT00027417

Last Updated: 2013-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Defects, Congenital

Keywords

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Congenital heart defects Hypoplastic left heart syndrome Complete atrioventricular canal defect Triostat Cardiac surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Liothyronine sodium/triiodothyronine

Intervention Type DRUG

Cardiopulmonary bypass and cardiac surgery

Intervention Type PROCEDURE

Placebo

bolus administration of Placebo immediately prior to CPB institution and after removal of aortic cross clamp, followed by repeated boluses

Group Type PLACEBO_COMPARATOR

Liothyronine sodium/triiodothyronine

Intervention Type DRUG

Cardiopulmonary bypass and cardiac surgery

Intervention Type PROCEDURE

Interventions

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Liothyronine sodium/triiodothyronine

Intervention Type DRUG

Cardiopulmonary bypass and cardiac surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michael Portman

OTHER

Sponsor Role lead

Responsible Party

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Michael Portman

Cardiologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michael Portman, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Childrens Hospital

Locations

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Children's Hospital and Regional Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Portman MA, Slee A, Olson AK, Cohen G, Karl T, Tong E, Hastings L, Patel H, Reinhartz O, Mott AR, Mainwaring R, Linam J, Danzi S; TRICC Investigators. Triiodothyronine Supplementation in Infants and Children Undergoing Cardiopulmonary Bypass (TRICC): a multicenter placebo-controlled randomized trial: age analysis. Circulation. 2010 Sep 14;122(11 Suppl):S224-33. doi: 10.1161/CIRCULATIONAHA.109.926394.

Reference Type DERIVED
PMID: 20837917 (View on PubMed)

Other Identifiers

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FD-R-001971-01

Identifier Type: -

Identifier Source: secondary_id

FD-R-1971-01

Identifier Type: -

Identifier Source: org_study_id