Protective Effect of Sivelestat Against Negative Pulmonary Function and Organ Dysfunction After Cardiovascular Surgery (PANDA VI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- The highest SOFA score of 7 days after surgery
研究概览
简要总结
Systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) are the major causes of death in patients with cardiovascular diseases. Therefore, the prevention of SIRS and MODS is of great clinical value, and immunomodulatory therapy with sivelestat may be beneficial. This study was designed to test the hypothesis that the administration of sivelestat during the acute phase of cardiovascular diseases will result in a reduced incidence of SIRS and MODS.
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 90 Years（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 emergency surgery were enrolled.
- •The patients' age between 18 ~90 years old.
- •Agree to participate in the study and sign the informed consent.
排除标准
- •Patients allergic to sivelestat sodium;
- •Lactating women and pregnant women;
- •Patients with mental diseases, drug and alcohol dependence;
- •Refuse to participate in this study and refuse to sign the informed consent.
研究组 & 干预措施
Blank control
The control group did not receive any intervention.
干预措施: Blank control (Drug)
Sivelestat
干预措施: Sivelestat (Drug)
结局指标
主要结局
The highest SOFA score of 7 days after surgery
时间窗: 7 days after surgery
The daily SOFA score after baseline was calculated for each patient on the basis of five organ systems: 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
- all-cause mortality(30 days after surgery)
研究者
Hong Liu
Principal Investigator of Cardiovascular Surgery
Nanjing Medical University