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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yong-Sun Choi, Yonsei University
ClinicalTrials.gov Identifier:
NCT01153360
First received: June 29, 2010
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Non-thyroidal Illness Syndrome
Drug: liothyronine sodium
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Peri-operative Oral Triiodothyronine Replacement Therapy to Decrease the Risk of Transient Atrial Fibrillation After Off-pump Coronary Artery Bypass Surgery

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • difference of hemodynamic performance and myocardial injury [ Time Frame: during surgery and 36 hr after surgery ] [ Designated as safety issue: No ]
    difference of hemodynamic performance and myocardial injury between the groups


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: June 2010
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01153360

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Yong-Sun Choi, MD, Ph.D Anesthesiology & Pain Medicine, Severance Hospital
  More Information

No publications provided

Responsible Party: Yong-Sun Choi, assistant professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01153360     History of Changes
Other Study ID Numbers: 4-2010-0086
Study First Received: June 29, 2010
Last Updated: July 23, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Euthyroid Sick Syndromes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 29, 2014