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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00289367

Enrollment

280

Registered

2006-02-09

Start date

2006-02-28

Completion date

2008-05-31

Last updated

2008-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief 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.

Interventions

DRUGTriiodothyronine

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

DRUGtriiodothyronine

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
incidence of atrial fibrillation	during hospitalization

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026