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Peri-operative Oral Triiodothyronine Replacement Therapy to Decrease the Risk of Transient Atrial Fibrillation After Off-pump Coronary Artery Bypass Surgery

NCT ID: NCT01153360

Last Updated: 2012-07-24

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

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-09-30

Brief Summary

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This study is planned to medicate oral T3(Liothyronine)to the patients who are planned to have OPCAB(off- pump coronary bypass graft surgery. The aim of this study was to assess the effects of oral triiodothyronine (T3) therapy on postoperative thyroid hormone concentrations, hemodynamic variables and outcomes in patients undergoing OPCAB in a randomized, controlled trial.

Detailed Description

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Conditions

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Non-thyroidal Illness Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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T3

triiodothyronine

Group Type EXPERIMENTAL

liothyronine sodium

Intervention Type DRUG

liothyronine sodium 20ug, every 12hour (before anesthetic induction, total 4 times)

cyanocobalamin

vitamin B12

Group Type ACTIVE_COMPARATOR

placebo

Intervention Type DRUG

vitamin B12

Interventions

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liothyronine sodium

liothyronine sodium 20ug, every 12hour (before anesthetic induction, total 4 times)

Intervention Type DRUG

placebo

vitamin B12

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who are undergoing Off-pump coronary artery bypass graft

Exclusion Criteria

* No normal sinus rhythm,
* History of thyroid disease
* Abnormal thyroid hormone
* Renal dysfunction
* Hepatic dysfunction
* LVEF \<30%
* Recent MI
* Active infection 1\~15
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Yong-Sun Choi

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yong-Sun Choi, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology & Pain Medicine, Severance Hospital

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2010-0086

Identifier Type: -

Identifier Source: org_study_id