Study of T3 on the Incidence of 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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

North Shore University Hospital

Manhasset, New York, 11030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triiodothyronine

Drug

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

Primary outcomes

incidence of atrial fibrillation

Time frame: during hospitalization

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

Thomas and Jeanne Elmezzi Foundation

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2008
First posted: Feb 9, 2006
Registry last updated: May 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed