Intermittent Normoxia Reduces Myocardial Reperfusion Injury (INCPB)
Effect of Intermittent Normoxic Cardiopulmonary Bypass on Myocardial Reperfusion Injury in Adult Valve Replacement
研究概览
详细说明
Methods:Patients meeting the requirement will be randomized into 2 groups: the control group received hyperoxic reperfusion (PaO2 180-250 mmHg) throughout CPB as routine; the treatment group underwent 3 cycles of 5/5 min normal/high oxygenation (PaO2 80-150/180-250 mmHg) during cardioplegia arrest, and maintained the same hyperoxia as the control group in the rest time of CPB. The clinical data of inotropes requirement, drainage, ventilation and intensive care time will be recorded. Venous blood samples will be taken perioperatively for detecting concentration of troponin I (cTnI), tumor necrosis factor-α , interleukin-6, 10, and malondialdehyde (MDA). Atrial biopsies will be removed before cardioplegia arrest and 30min after aortic de-clamping to determine the extent of neutrophil infiltration (myeloperoxidase activity), NFkB binding DNA activity, and gene expression of inflammatory factors (TNF-α, IL-6, 10).
Statistical analysis:A sample size of at least 32 patients in each group was needed to have a power of 90%, significance at the two-side 5% level, on the basis that a SD of 0.2 ng/ml and a difference in peak serum cTnI release of about 0.15 ng/ml between control and conditioned patients was determined.
Expected Results: The treatment group will have significantly lower release of cTnI, inflammatory factors, and MDA during CPB and afterwards. Intermittent normoxia may be related to less myocardial inflammation characterized by decreased myeloperoxidase activity, gene expression of inflammatory factors, the later may result from reduced activity of NFkB binding to DNA after reperfusion.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Hunan
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Changsha City、Hunan、中国、410008
- 招聘中
- Department of Cardiothoracic Surgery, Xiangya Hospital, Central South University
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接触:
- Wanjun, Luo
- 电话号码:86-731-89753703
- 邮箱:luowanjun@yahoo.com
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副研究员:
- Li Li, M.D.
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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:
- rheumatic heart valve disease requiring selective aortic or double valve(aortic and mitral valve) replacement
Exclusion Criteria:
- infective endocarditis congenital valve disease previous cardiac surgery complicated with diabetes, coronary artery disease, hypertension or peripheral vascular disease.
receiving aspirin, corticosteroids, angiotensin-converting enzyme inhibitors or statin perioperatively
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 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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实验性的:Intermittent normoxia
Repeated brief normoxic reperfusion during cardioplegia arrest in adult valve replacement
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3 cycles of 5/5 min normoxia/hyperoxic reperfusion during cardioplegia arrest in adult valve replacement
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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 |
---|---|
plasma concentration of troponin I
大体时间:within the first 24h after cardiac surgery
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within the first 24h after cardiac surgery
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次要结果测量
结果测量 |
大体时间 |
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gene expression of TNFa, IL-6, and IL-10 in myocardium
大体时间:30 min after aotic de-clamping
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30 min after aotic de-clamping
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
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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intermittent normoxia的临床试验
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Beth Israel Deaconess Medical CenterUnited States Department of Defense终止
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Centre Hospitalier Universitaire de Saint Etienne终止
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University of MichiganNational Institutes of Health (NIH)主动,不招人法洛四联症 | 体外循环 | 左心发育不全综合征 | 大动脉转位 | 双出口右心室,肺下室间隔缺损 | 肺动脉闭锁伴室间隔缺损 | 动脉干 | 总肺静脉异常回流 | 右心室双出口合并主动脉瓣下室间隔缺损和肺动脉狭窄美国