NCT00636584Unknown4 期
Does Sodium Nitroprusside Infusion Affect Thyroidal Function in Patients Undergoing Coronary Artery Bypass Grafting, a Prospective Randomized Clinical Trial.
Kavaklıdere Umut Hospital1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- free T3
研究概览
简要总结
Whether use of SNP during cardiac surgery has any effect on thyroid function has not yet been investigated in humans. The aim of this study was to investigate the effects of SNP administration during the rewarming period of cardiac operations on circulating levels of thyroid hormones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients without history of:
- •thyroidal disease
- •hypertension
- •pulmonary disease
- •peripheral vascular disease
- •recent myocardial infarction within the week prior to operation
- •unstable angina pectoris
- •liver or kidney dysfunction
- •morbid obesity
- •sulfonylurea intake
排除标准
- •Patients who needed positive inotropic pharmacologic support during or after the operation
- •Patients who developed atrial fibrillation in the post operative period requiring amiodarone therapy
- •In addition, patients receiving any medication known to interfere with any step of thyroid hormone metabolism such as
- •amiodarone
- •propranolol
- •furosemide
- •non-steroidal anti-inflammatory agents
- •estrogens
- •diphenylhydantoin
- •spironolactone
研究组 & 干预措施
1
Experimental
arm1: sodium nitroprusside group
干预措施: sodium nitroprusside (Drug)
2
Placebo Comparator
arm2: control group,saline infused instead of sodium nitroprusside
干预措施: placebo (Drug)
结局指标
主要结局
free T3
时间窗: on admission, prior to operation, at the beginning of CPB, following CPB, at first, third and fifth postoperative days
次要结局
- total T3(on admission, prior to operation, at the beginning of CPB, following CPB, on the first, third and fifth postoperative days)
研究者
研究点 (1)
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