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

Verified by: North Shore Long Island Jewish Health System, May 2008
First Received: February 7, 2006 | Last Updated: May 19, 2008 | Phase: Phase 1 | Start Date: February 2006
Overall Status: Completed | Estimated Enrollment: 280
  • …
  • Tell a FriendPrint

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...

Brief Summary

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

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.

  • 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
  • Study Primary Completion Date: August 2006

Intervention(s) in this Clinical Trial

  • 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • incidence of atrial fibrillation
    • Time Frame: during hospitalization
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: North Shore Long Island Jewish Health System Other

Overall Clinical Trial Officials and Contacts

Irwin Klein, MD Principal Investigator North Shore University Hospital  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00289367

Study ID Number: 05-075

ClinicalTrials.gov Identifier: NCT00289367

Health Authority: United States: Food and Drug Administration

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00289367