Peri-operative Oral Triiodothyronine Replacement Therapy to Decrease the Risk of Transient Atrial Fibrillation After Off-pump Coronary Artery Bypass Surgery
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 29, 2010
CompletedFirst Posted
Study publicly available on registry
June 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJuly 24, 2012
July 1, 2012
1.2 years
June 29, 2010
July 23, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
difference of hemodynamic performance and myocardial injury
during surgery and 36 hr after surgery
Other Outcomes (1)
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
Study Arms (2)
T3
EXPERIMENTALtriiodothyronine
cyanocobalamin
ACTIVE COMPARATORvitamin B12
Interventions
liothyronine sodium 20ug, every 12hour (before anesthetic induction, total 4 times)
Eligibility Criteria
You may qualify if:
- Patients who are undergoing Off-pump coronary artery bypass graft
You may not qualify if:
- No normal sinus rhythm,
- History of thyroid disease
- Abnormal thyroid hormone
- Renal dysfunction
- Hepatic dysfunction
- LVEF \<30%
- Recent MI
- Active infection 1\~15
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yong-Sun Choi, MD, Ph.D
Anesthesiology & Pain Medicine, Severance Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
June 29, 2010
First Posted
June 30, 2010
Study Start
June 1, 2010
Primary Completion
August 1, 2011
Study Completion
September 1, 2011
Last Updated
July 24, 2012
Record last verified: 2012-07