Effect of Ulinastatin on Postoperative Systemic Inflammatory Response in Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- bactericidal permeability increasing protein
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective cardiac surgery employing CPB
排除标准
- •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
研究组 & 干预措施
placebo
normal saline, same amount, iv
干预措施: placebo (Drug)
ulinastatin
5000 unit/kg iv
干预措施: ulinastatin (Drug)
结局指标
主要结局
bactericidal permeability increasing protein
时间窗: 5-30 min before the end of anesthesia
interleukin-6
时间窗: 5-30 min before the end of anesthesia
tumor necrosis factorTNF-α
时间窗: 5-30 min before the end of anesthesia
次要结局
- Creatine kinase-MB(before anesthesia, 24 hour after the end of anesthesia)
- troponin I(before anesthesia, 24 hour after the end of anesthesia)
- C-reactive protein(before anesthesia, 24 hour after the end of anesthesia)
- serum creatinine(before anesthesia, 24 hour after the end of anesthesia)
- PaO2/FiO2 ratio(before anesthesia, 24 hour after the end of anesthesia)
研究者
Tae-Yop Kim, MD PhD
Professor of Anesthesiology
Konkuk University Medical Center