Protective Effect of Ulinastatin and Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA XI)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- The mean Sequential Organ Failure Assessment (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 acute aortic syndrome (AAS). Therefore, the prevention of SIRS and MODS is of great clinical value, and immunomodulatory therapy with thymosin alpha
1 in addition to antiinflammatory treatment may be beneficial. This study was designed to test the hypothesis that the administration of Ulinastatin and Thymosin α1 during the acute phase of AAS 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
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 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 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 Thymosin α1 or Ulinastatin;
- •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
UT Group
Ulinastatin (100000U TID for 5 days) and Thymosin alpha 1 (1.6 mg q12h for 5 days) immediately after surgery
干预措施: Ulinastatin and Thymosin α1 (Drug)
Control Group
Ulinastatin (100000U TID for 5 days) immediately after surgery
干预措施: Ulinastatin only (Drug)
结局指标
主要结局
The mean Sequential Organ Failure Assessment (SOFA) score of 7 days after surgery
时间窗: within the prior 7 days after surgery.
The occurrence of new-onset organ failure and new-onset persistent organ failure (Sequential Organ Failure Assessment (SOFA) score. New-onset is defined as events that occur after randomization and not present 24 hours before randomization.
次要结局
未报告次要终点
研究者
Hong Liu
Principal Investigator of Department of Cardiovascular Surgery
Nanjing Medical University