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临床试验/NCT00289367
NCT00289367已完成1 期

Randomized Prospective Study of T3 on the Incidence of Post-Operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Northwell Health2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2006年2月最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
280
试验地点
2
主要终点
incidence of atrial fibrillation

研究概览

简要总结

The purpose of this project is to see whether treatment with a thyroid hormone, called triiodothyronine or T3, following open heart surgery reduces the risk of developing atrial fibrillation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients requiring CABG or valve repair/replacement surgery.
  • Patient must be able to provide informed consent.

排除标准

  • Patients less than 18 or over 85 years of age.
  • Patients less than 50kg or greater than 120kg.
  • Patients currently with endocrine disorders, excluding diabetes.
  • Patients currently with thyroid dysfunction (e.g., hyper- hyperthyroidism, goiter, Grave's disease), myxedema, or myxedema coma, even if treated.
  • Patients currently receiving thyroid replacement therapy.
  • Patients currently receiving Ketamine, levarterenol or dietary (non-food) iodine supplementation.
  • Patients who have received any investigational drugs within the previous one month or five half-lives of the drug.
  • Patients who are pregnant. Pregnancy testing will be done for women of child-bearing potential.
  • Patients currently in atrial fibrillation.

结局指标

主要结局

incidence of atrial fibrillation

时间窗: during hospitalization

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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