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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Triiodothyronine
triiodothyronine
Sponsored by
Northwell Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • North Shore University Hospital

Outcomes

Primary Outcome Measures

incidence of atrial fibrillation

Secondary Outcome Measures

Full Information

First Posted
February 7, 2006
Last Updated
May 19, 2008
Sponsor
Northwell Health
Collaborators
Thomas and Jeanne Elmezzi Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00289367
Brief Title
Study of T3 on the Incidence of Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Official Title
Randomized Prospective Study of T3 on the Incidence of Post-Operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Northwell Health
Collaborators
Thomas and Jeanne Elmezzi Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Triiodothyronine
Intervention Description
0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.
Intervention Type
Drug
Intervention Name(s)
triiodothyronine
Intervention Description
IV formulation - Triostat, 0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.
Primary Outcome Measure Information:
Title
incidence of atrial fibrillation
Time Frame
during hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irwin Klein, MD
Organizational Affiliation
North Shore University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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