NCT00027417

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2001

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

August 5, 2013

Status Verified

August 1, 2013

Enrollment Period

6.3 years

First QC Date

December 5, 2001

Last Update Submit

August 1, 2013

Conditions

Heart Defects, Congenital

Keywords

Congenital heart defectsHypoplastic left heart syndromeComplete atrioventricular canal defectTriostatCardiac surgery

Outcome Measures

Primary Outcomes (1)

  • duration of mechanical ventilation after cardiopulmonary bypass.

    Reducing the length of ventilatory support minimizes other postoperative complications, which can contribute to morbidity.

    0 to 72 hours

Secondary Outcomes (1)

  • Assess other parameters

    0 to 72 hrs

Study Arms (2)

Liothyronine Sodium/Triiodothyronine

ACTIVE COMPARATOR

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/triiodothyronineProcedure: Cardiopulmonary bypass and cardiac surgery

Placebo

PLACEBO COMPARATOR

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

Drug: Liothyronine sodium/triiodothyronineProcedure: Cardiopulmonary bypass and cardiac surgery

Interventions

Liothyronine sodium/triiodothyronineDRUG
Liothyronine Sodium/TriiodothyroninePlacebo
Cardiopulmonary bypass and cardiac surgeryPROCEDURE
Liothyronine Sodium/TriiodothyroninePlacebo

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Certain additional defects and/or requirement for additional surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital and Regional Medical Center

Seattle, Washington, 98105, United States

Location

Related Publications (1)

  • 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.

    PMID: 20837917DERIVED

MeSH Terms

Conditions

Heart Defects, CongenitalHypoplastic Left Heart SyndromeEndocardial Cushion Defects

Interventions

TriiodothyronineCardiopulmonary BypassCardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart Septal Defects

Intervention Hierarchy (Ancestors)

ThyroninesThyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsThyroxineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsExtracorporeal CirculationSurgical Procedures, OperativeCardiovascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Michael Portman, MD

    Seattle Childrens Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

December 5, 2001

First Posted

December 7, 2001

Study Start

April 1, 2001

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

August 5, 2013

Record last verified: 2013-08

Locations

US(1)