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

Non-thyroidal Illness Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153360
• Other study ID #: 4-2010-0086
• Status: Completed
• Phase: N/A
• First received: June 29, 2010
• Last updated: July 23, 2012
• Start date: June 2010
• Est. completion date: September 2011

Study information

• Verified date: July 2012
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Atrial Fibrillation
• Euthyroid Sick Syndromes
• Non-thyroidal Illness Syndrome

Intervention

Drug:
• liothyronine sodium
liothyronine sodium 20ug, every 12hour (before anesthetic induction, total 4 times)
• placebo
vitamin B12

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	major morbidity endpoints including acute renal failure, cardiovascular failure, stroke, mediastinitis, need for ventilator support for >48 h, and new onset atrial fibrillation		until discharge of hospital	Yes
Primary	compare the serum T3 concentrations and the number of patients with serum T3 concentrations below the normal range between the groups		until 36 hours after surgery	Yes
Secondary	difference of hemodynamic performance and myocardial injury	difference of hemodynamic performance and myocardial injury between the groups	during surgery and 36 hr after surgery	No