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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-12-31

Study Completion Date

1997-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Relationship Between Functional Health Status and Ventricular Performance After Fontan--Pediatric Heart Network

NCT00132782

Defect, Congenital Heart Arrhythmia

COMPLETED

The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease

NCT00480740

Cardiac Transplant Patent Ductus Arterious Atrial Septal Defect +1 more

COMPLETED PHASE3

Thyroid Hormones in Critically Ill Children

NCT00664079

Hypotension Respiratory Failure

TERMINATED

Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology

NCT01273857

Hypoplastic Left Heart Syndrome Single Ventricle Heart Failure

COMPLETED PHASE1

Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation

NCT02498444

Single Ventricle

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tricuspid Atresia Heart Defects, Congenital

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

liothyronine I 131

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No