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Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004828
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
Children's Hospital and Health Center
Information provided by:
FDA Office of Orphan Products Development

Tracking Information
First Submitted Date  ICMJE February 24, 2000
First Posted Date  ICMJE February 25, 2000
Last Update Posted Date March 25, 2015
Study Start Date  ICMJE December 1994
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
Official Title  ICMJE Not Provided
Brief Summary

OBJECTIVES: I. Determine the pharmacokinetics of exogenous liothyronine administered in children undergoing the modified Fontan procedure.

II. Determine the liothyronine supplementation dose that counters the fall in serum liothyronine concentrations and provides the greatest potential myocardial benefit after the modified Fontan procedure.

III. Evaluate the potential toxicity of exogenous liothyronine administered in children undergoing a modified Fontan procedure.

Detailed Description

PROTOCOL OUTLINE: This is a randomized, placebo controlled, dose escalation study.

Initially, patients are randomized to receive either 1 of 3 different dosages of liothyronine or placebo after undergoing the Fontan procedure. If no unacceptable toxicity is observed in this group, a third dose level of liothyronine is added to the randomization. A total of 7 patients are enrolled at each dose level. All randomized study drugs are administered by continuous infusion over 1 hour after surgery.

Cardiac function is assessed 5 days after surgery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE
  • Tricuspid Atresia
  • Heart Defects, Congenital
Intervention  ICMJE Drug: liothyronine I 131
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
28
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 1997
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE
  • Single ventricle congenital cardiac malformation
  • Must undergo modified Fontan procedure
  • No concurrent medications known to interfere with thyroid metabolism including propranolol and amiodarone
  • No hepatic dysfunction
  • No renal dysfunction
  • No pre-existing thyroid dysfunction
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00004828
Other Study ID Numbers  ICMJE 199/13357
CHSD-585
CHSD-FDR001195
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE FDA Office of Orphan Products Development
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Children's Hospital and Health Center
Investigators  ICMJE
Study Chair: Richard Mainwaring Children's Hospital and Health Center
PRS Account FDA Office of Orphan Products Development
Verification Date June 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP