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

This study has been completed.

First Received on February 7, 2006. Last Updated on May 19, 2008 History of Changes

Sponsor:	North Shore Long Island Jewish Health System
Collaborator:	Thomas and Jeanne 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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Randomized Prospective Study of T3 on the Incidence of Post-Operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Heart Surgery

Drug Information available for: Liothyronine sodium Triiodothyronine

U.S. FDA Resources

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

Thomas and Jeanne Elmezzi Foundation

Investigators

Principal Investigator:

Irwin Klein, MD

North Shore University Hospital

More Information

No publications provided

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

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012