Study of T3 on the Incidence of Atrial Fibrillation in Patients Undergoing Cardiac Surgery - Full Text View

Study of T3 on the Incidence of Atrial Fibrillation in Patients Undergoing Cardiac Surgery

This study has been completed.

Sponsors and Collaborators:	North Shore Long Island Jewish Health System Elmezzi Foundation
Information provided by:	North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:	NCT00289367

Purpose

The purpose of this project is to see whether treatment with a thyroid hormone, called triiodothyronine or T3, following open heart surgery reduces the risk of developing atrial fibrillation.

Condition	Intervention	Phase
Atrial Fibrillation	Drug: Triiodothyronine Drug: triiodothyronine	Phase I

Genetics Home Reference related topics:

Brugada syndrome familial atrial fibrillation short QT syndrome

Drug Information available for:

Triiodothyronine Liothyronine sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study

Official Title:	Randomized Prospective Study of T3 on the Incidence of Post-Operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:

incidence of atrial fibrillation [ Time Frame: during hospitalization ] [ Designated as safety issue: No ]

Estimated Enrollment:	280
Study Start Date:	February 2006
Study Completion Date:	May 2008
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Intervention Details:

0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.

IV formulation - Triostat, 0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients requiring CABG or valve repair/replacement surgery.
Patient must be able to provide informed consent.

Exclusion Criteria:

Patients less than 18 or over 85 years of age.
Patients less than 50kg or greater than 120kg.
Patients currently with endocrine disorders, excluding diabetes.
Patients currently with thyroid dysfunction (e.g., hyper- hyperthyroidism, goiter, Grave's disease), myxedema, or myxedema coma, even if treated.
Patients currently receiving thyroid replacement therapy.
Patients currently receiving Ketamine, levarterenol or dietary (non-food) iodine supplementation.
Patients who have received any investigational drugs within the previous one month or five half-lives of the drug.
Patients who are pregnant. Pregnancy testing will be done for women of child-bearing potential.
Patients currently in atrial fibrillation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289367

Locations


United States, New York
	North Shore University Hospital
	Manhasset, New York, United States, 11030

Sponsors and Collaborators

North Shore Long Island Jewish Health System

Elmezzi Foundation

Investigators


Principal Investigator:	Irwin Klein, MD	North Shore University Hospital

More Information

Responsible Party:	North Shore University Hospital ( Irwin Klein )
Study ID Numbers:	05-075
First Received:	February 7, 2006
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00289367
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Heart Diseases

Atrial Fibrillation

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 22, 2008