Ulinastatin's Anti-inflammatory Reaction in Cardiac Surgery
关键词
抽象
描述
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.
日期
| 最后验证: | 12/31/2011 |
| 首次提交: | 01/19/2012 |
| 提交的预估入学人数: | 01/24/2012 |
| 首次发布: | 01/25/2012 |
| 上次提交的更新: | 01/24/2012 |
| 最近更新发布: | 01/25/2012 |
| 实际学习开始日期: | 02/29/2008 |
| 预计主要完成日期: | 05/31/2008 |
| 预计完成日期: | 07/31/2008 |
状况或疾病
干预/治疗
Drug: ulinastatin
Drug: placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Placebo Comparator: placebo normal saline, same amount, iv | Drug: placebo placebo (the same amount of normal saline) iv before the initiation of CPB |
| Active Comparator: ulinastatin 5000 unit/kg iv | Drug: ulinastatin ulinastatin 5000 unit/kg iv before the initiation of CPB |
资格标准
| 有资格学习的年龄 | 25 Years 至 25 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. bactericidal permeability increasing protein [5-30 min before the end of anesthesia]
2. interleukin-6 [5-30 min before the end of anesthesia]
3. tumor necrosis factorTNF-α [5-30 min before the end of anesthesia]
次要成果指标
1. Creatine kinase-MB [before anesthesia, 24 hour after the end of anesthesia]
2. troponin I [before anesthesia, 24 hour after the end of anesthesia]
3. C-reactive protein [before anesthesia, 24 hour after the end of anesthesia]
4. serum creatinine [before anesthesia, 24 hour after the end of anesthesia]
5. PaO2/FiO2 ratio [before anesthesia, 24 hour after the end of anesthesia]
