Protective Effect of Ulinastatin Against Negative Inflammatory Response and Organ Dysfunction After Acute Type a Aortic Dissection Surgery (PANDA I)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 2
- 主要终点
- SOFA score
研究概览
简要总结
Acute Aortic Syndrome (AAS) is a common feature of acute aortic wall events, including aortic dissection, intramural hematoma, aortic ulceration and aortic trauma, and occurs in up to 35 cases per 100,000 cases per year between the ages of 65 and 75 years. Ulinastatin has antiinflammatory activity and suppresses the infiltration of neutrophils and the release of elastase and chemical mediators from neutrophils. Recent studies have shown that ulinastatin may be cytoprotective against ischemia-reperfusion injury in the liver, kidney, heart, and lung. The authors aim to examine the association between decreased release of inflammatory response to urinary trypsin inhibitor treatment and decreased myocardial and lung injury after acute aortic syndrome surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients are conformed to 2010 ACC/AHA guidelines for the diagnosis and treatment of thoracic aortic disease (TAD) within two weeks of onset;
- •Patients with type a acute aortic syndrome confirmed clinically and radiologically and planning to undergo aortic surgery were enrolled.
- •The patients' age of 18 years or older.
- •Agree to participate in the study and sign the informed consent.
排除标准
- •Patients allergic to Ulinastatin;
- •Lactating women and pregnant women;
- •Patients with mental diseases;
- •Refuse to participate in this study and refuse to sign the informed consent.
研究组 & 干预措施
Ulinastatin
Ulinastatin 10 0000 Units is taken intravenously three times a day.
干预措施: Ulinastatin (Drug)
Blank control
Blank control.
干预措施: Blank control (Drug)
结局指标
主要结局
SOFA score
时间窗: mean SOFA score 7 days after surgery
The daily SOFA score after baseline was calculated for each patient on the basis of organ systems: neurologic, cardiovascular, respiratory, renal, hepatic, and coagulation systems. (Scores for each system range from 0 to 4, with higher scores indicating more severe organ-system dysfunction)
次要结局
- Mortality(30 days after surgery)
研究者
Hong Liu
Investigator of Nanjing Medical University
Nanjing Medical University