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
Verified date | July 2012 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Severance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT00591032 -
Approach to a Quantitative Follow-up of Non-thyroidal Illness Syndrome
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