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

July 23, 2012 updated by: Yong-Sun Choi, Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: T3
triiodothyronine
Drug: liothyronine sodium
liothyronine sodium 20ug, every 12hour (before anesthetic induction, total 4 times)
ACTIVE_COMPARATOR: cyanocobalamin
vitamin B12
Drug: placebo
vitamin B12

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
compare the serum T3 concentrations and the number of patients with serum T3 concentrations below the normal range between the groups
Time Frame: until 36 hours after surgery
until 36 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference of hemodynamic performance and myocardial injury
Time Frame: during surgery and 36 hr after surgery
difference of hemodynamic performance and myocardial injury between the groups
during surgery and 36 hr after surgery

Other Outcome Measures

Outcome Measure
Time Frame
major morbidity endpoints including acute renal failure, cardiovascular failure, stroke, mediastinitis, need for ventilator support for >48 h, and new onset atrial fibrillation
Time Frame: until discharge of hospital
until discharge of hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Yong-Sun Choi, MD, Ph.D, Anesthesiology & Pain Medicine, Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

June 29, 2010

First Submitted That Met QC Criteria

June 29, 2010

First Posted (ESTIMATE)

June 30, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 24, 2012

Last Update Submitted That Met QC Criteria

July 23, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2010-0086

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-thyroidal Illness Syndrome

Clinical Trials on liothyronine sodium

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe