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Liothyronine in Children with Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Liothyronine in Children with Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Liothyronine in Children with Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure Clinical research trials and Liothyronine in Children with Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Liothyronine in Children with Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure. Liothyronine in Children with Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Liothyronine in Children with Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure clinical trial. Participants oftentimes recieve the finest healthcare available for their Liothyronine in Children with Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Liothyronine in Children with Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure  Liothyronine in Children with Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
Liothyronine in Children with Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
For Condition: Tricuspid Atresia,Heart Defects, Congenital
Status: Completed
Sponsor(s): FDA Office of Orphan Products Development , Children's Hospital and Health Center
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Placebo Control
Minimum Age/Maximum Age: /17 Years
Genders: Both
Protocol Entry Criteria: - 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
Total Enrollment: 28
Location and Contact Information:
Overall Study Official:
RichardMainwaring, Study Chair, Children's Hospital and Health Center
Additional Information:
Study ID Numbers: 199/13357; CHSD-585,CHSD-FDR001195
Study Start Date: December 1994
Record last reviewed: June 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004828
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1. Liothyronine in Children with Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
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Liothyronine in Children with Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
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