Ulinastatin's Anti-inflammatory Reaction in Cardiac Surgery (ulistin)
Effect of Ulinastatin on Postoperative Systemic Inflammatory Response in Cardiac Surgery
The purpose of the present study is to determine whether ulinastatin, urinary anti-trypsin inhibitor, attenuates cardiopulmonary bypass (CPB)-activated systemic inflammatory response in cardiac surgery with CPB.
Serial measurements and analysis of several inflammatory cytokines (bactericidal permeability increasing protein, interleukin-6, tumor necrosis factor-α)as well as markers of cardiac injury, renal impairment and oxygenation profile will be performed to determine ulinastatin's efficacy.
研究概览
详细说明
Applying aortic cross-clamp (ACC) and cardiopulmonary bypass (CPB) for cardiac surgery produces variable systemic inflammatory reactions. As a common complication of those reactions, pulmonary dysfunction, which usually indicated by postoperative hypoxemia, is frequently associated with cardiac surgery employing CPB and has been used as a major predictor of morbidity and mortality.
Circulating humoral and cellular factors are involved in the development of the systemic inflammatory reactions including organ dysfunction. So far, many studies analyzed the concentration of inflammatory marker (cytokine) to determine the degree of systemic inflammatory responses in various conditions.
Ulinastatin has anti-inflammatory activity and suppresses the infiltration of neutrophils. Previous studies suggested ulinastatin's cytoprotective effect against ischemia-reperfusion injury in major organs and its inhibition of inflammatory marker production.
The purpose of the present study is to determine ulinastatin's possible protective efficacy of in attenuating CPB-activated systemic inflammatory response regarding postoperative cardiac, renal and pulmonary dysfunction in cardiac surgery with CPB. Serial measurements and analysis of several inflammatory cytokines, such as bactericidal permeability increasing protein (BPI), interleukin (IL)-6, tumor necrosis factor (TNF)-α, as well as markers of cardiac injury, renal impairment and oxygenation profile, such as creatine kinase-MB (CK-MB), troponin I (TnI), C-reactive protein (CRP), arterial O2 tension /inspired O2 fraction (PaO2/FiO2 ratio), will be performed to this purpose.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Seoul、大韩民国、143-729
- Konkuk University Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- elective cardiac surgery employing CPB
Exclusion Criteria:
- urgent/emergency surgery,
- previous heart surgery,
- combined CABG and valve surgery,
- age > 75 yrs,
- left ventricular ejection fraction < 0.45,
- diabetes treated with insulin,
- active gastropathic disorder,
- treatment for chronic obstructive pulmonary disease,
- preoperative use of steroids
- postoperative re-operation due to bleeding control
- pre and postoperative renal replacement therapy
- left ventricular assist device implantation
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较:placebo
normal saline, same amount, iv
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placebo (the same amount of normal saline) iv before the initiation of CPB
其他名称:
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有源比较器:ulinastatin
5000 unit/kg iv
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ulinastatin 5000 unit/kg iv before the initiation of CPB
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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bactericidal permeability increasing protein
大体时间:5-30 min before the end of anesthesia
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5-30 min before the end of anesthesia
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interleukin-6
大体时间:5-30 min before the end of anesthesia
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5-30 min before the end of anesthesia
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tumor necrosis factorTNF-α
大体时间:5-30 min before the end of anesthesia
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5-30 min before the end of anesthesia
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Creatine kinase-MB
大体时间:before anesthesia, 24 hour after the end of anesthesia
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before anesthesia, 24 hour after the end of anesthesia
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troponin I
大体时间:before anesthesia, 24 hour after the end of anesthesia
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before anesthesia, 24 hour after the end of anesthesia
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C-reactive protein
大体时间:before anesthesia, 24 hour after the end of anesthesia
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before anesthesia, 24 hour after the end of anesthesia
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serum creatinine
大体时间:before anesthesia, 24 hour after the end of anesthesia
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before anesthesia, 24 hour after the end of anesthesia
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PaO2/FiO2 ratio
大体时间:before anesthesia, 24 hour after the end of anesthesia
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before anesthesia, 24 hour after the end of anesthesia
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合作者和调查者
出版物和有用的链接
一般刊物
- Nakanishi K, Takeda S, Sakamoto A, Kitamura A. Effects of ulinastatin treatment on the cardiopulmonary bypass-induced hemodynamic instability and pulmonary dysfunction. Crit Care Med. 2006 May;34(5):1351-7. doi: 10.1097/01.CCM.0000215110.55899.AE.
- Hill GE. Cardiopulmonary bypass-induced inflammation: is it important? J Cardiothorac Vasc Anesth. 1998 Apr;12(2 Suppl 1):21-5.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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