Effect of Intermittent Normoxic Cardiopulmonary Bypass on Myocardial Reperfusion Injury in Adult Valve Replacement
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- plasma concentration of troponin I
研究概览
简要总结
This study aims to determine the effect of intermittent normoxic cardiopulmonary bypass (CPB) on inflammatory response, oxidative stress and myocardial reperfusion injury in adult patients undergoing valve replacement. The investigators hypothesized that nuclear factor kappa B (NFkB) was involved in regulating gene expression of myocardial inflammatory factor.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •rheumatic heart valve disease requiring selective aortic or double valve(aortic and mitral valve) replacement
排除标准
- •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
结局指标
主要结局
plasma concentration of troponin I
时间窗: within the first 24h after cardiac surgery
次要结局
- gene expression of TNFa, IL-6, and IL-10 in myocardium(30 min after aotic de-clamping)