We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00289367
First Posted: February 9, 2006
Last Update Posted: May 20, 2008
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.
Collaborator:
Thomas and Jeanne Elmezzi Foundation
Information provided by:
Northwell Health
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Northwell Health:

Primary Outcome Measures:
  • incidence of atrial fibrillation [ Time Frame: during hospitalization ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289367


Locations
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
Thomas and Jeanne Elmezzi Foundation
Investigators
Principal Investigator: Irwin Klein, MD North Shore University Hospital
  More Information

Responsible Party: Irwin Klein, North Shore University Hospital
ClinicalTrials.gov Identifier: NCT00289367     History of Changes
Other Study ID Numbers: 05-075
First Submitted: February 7, 2006
First Posted: February 9, 2006
Last Update Posted: May 20, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes