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

NCT ID: NCT00289367

Last Updated: 2008-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Triiodothyronine

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

Intervention Type DRUG

triiodothyronine

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thomas and Jeanne Elmezzi Foundation

OTHER

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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North Shore University Hospital

Principal Investigators

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Irwin Klein, MD

Role: PRINCIPAL_INVESTIGATOR

North Shore University Hospital

Locations

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North Shore University Hospital

Manhasset, New York, United States

Site Status

Countries

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United States

Other Identifiers

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05-075

Identifier Type: -

Identifier Source: org_study_id