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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

Primary Purpose

Non-thyroidal Illness Syndrome

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

liothyronine sodium

placebo

About this trial

This is an interventional supportive care trial for Non-thyroidal Illness Syndrome

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cyanocobalamin

Arm Description

triiodothyronine

vitamin B12

Outcomes

Primary Outcome Measures

compare the serum T3 concentrations and the number of patients with serum T3 concentrations below the normal range between the groups

Secondary Outcome Measures

difference of hemodynamic performance and myocardial injury

difference of hemodynamic performance and myocardial injury between the groups

Full Information

NCT ID

NCT01153360

First Posted

June 29, 2010

Last Updated

July 23, 2012

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01153360

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Non-thyroidal Illness Syndrome

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

triiodothyronine

Arm Title

cyanocobalamin

Arm Type

Active Comparator

Arm Description

vitamin B12

Intervention Type

Drug

Intervention Name(s)

liothyronine sodium

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

vitamin B12

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

difference of hemodynamic performance and myocardial injury

Description

difference of hemodynamic performance and myocardial injury between the groups

Time Frame

during surgery and 36 hr after surgery

Other Pre-specified Outcome Measures:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yong-Sun Choi, MD, Ph.D

Organizational Affiliation

Anesthesiology & Pain Medicine, Severance Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Severance Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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