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Completed

NCT Number: NCT01153360

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

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.

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Key information

Conditions

Non-thyroidal Illness Syndrome Endocrine System Diseases Euthyroid Sick Syndromes Thyroid Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liothyronine Sodium

Drug

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

Placebo

Drug

vitamin B12

Primary outcomes

  1. 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 outcomes

  1. difference of hemodynamic performance and myocardial injury

    Time frame: during surgery and 36 hr after surgery

    difference of hemodynamic performance and myocardial injury between the groups

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

    Time frame: until discharge of hospital

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 30, 2010
Registry last updated
Jul 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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