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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289367
• Other study ID #: 05-075
• Status: Completed
• Phase: Phase 1
• First received: February 7, 2006
• Last updated: May 19, 2008
• Start date: February 2006
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: May 2008
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
United States	North Shore University Hospital	Manhasset	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Thomas and Jeanne Elmezzi Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of atrial fibrillation		during hospitalization	No