Mechanism and Early Intervention Research on Acute Lung Injury During Emergence Surgery of Acute Stanford A Aortic Dissection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 220
- 主要终点
- perioperative outcome and improve of ALI
研究概览
简要总结
The morbidity rate of Stanford A type Acute Aortic Dissection(AAD) has been increasing, about 5-10/100,000* per year. Emergency surgery has been the main treatment for Acute Aortic Dissection, however perioperative mortality rate can be as high as 15~30%. Acute lung injury (ALI) is one of the main complications that happen during the perioperative period, which by itself covers 30%-50% of the overall mortality rate. Both domestic and foreign countries lack researches on risk factors, pathogenesis, disease progression and outcome of ALI, which happen during the perioperative period of Acute Aortic Dissection patients.
This topic study follow projects in the preoperative of Acute Aortic Dissection'surgery
- hemodynamic changes (aortic dissection resulting in acute aortic regurgitation, cardiac tamponade and proximal high blood pressure)
- ischemia - reperfusion injury of aortic dissection distal organ
- Aortic intima-media exposure cause coagulation / fibrinolytic system function disorder
- systemic inflammatory response syndrome; use relevant clinical radiographic parameters, indicators of respiratory mechanics (oxygenation index and lung injury index) and biochemical indicators.
To discuss risk factors and possible mechanisms of ADD patients with pre-operative ALI and observe their influences on the progress and prognosis of AAD, to explore early intervention in the preoperative for possible risk factors and mechanisms and to evaluate their influences on the prognosis, to achieve the purpose of reducing AAD perioperative mortality of ALI and medical expenses.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •AAD patients within 48 hrs of onset who are prepared for aortic surgery
- •Age between 18 and 70
- •Willing to sign the informed consent
排除标准
- •A history of chronic respiratory disease before onset
- •A history of chronic heart failure or coronary heart disease before onset
- •A history of chronic liver or kidney dysfunction before onset
- •Severe central nervous system syndrome after admission
- •Refuse to sign the informed consent
研究组 & 干预措施
Tranexamic acid group
tranexamic acid ,intravenous 30mg/kg/d,Preoperative
干预措施: Tranexamic acid (Drug)
Edaravone group
edaravone, iv, 1mg/kg/d,Preoperative
干预措施: Edaravone (Drug)
Ulinastatin group
Ulinastatin ,iv,20,000 U /kg/d,Preoperative
干预措施: Ulinastatin (Drug)
结局指标
主要结局
perioperative outcome and improve of ALI
时间窗: Period from 48 hours before surgery to 12 hours after ICU
indicators * chest imaging (preoperative, 12 hours after ICU); * arterial blood gases and alveolar-arterial oxygen difference (before surgery, and immediately after induction of anesthesia, before surgery ends and 12 hours after ICU); * respiratory mechanics (immediately after induction of anesthesia, before the end of surgery and 12 hours after ICU); including peak airway pressure, plateau pressure, dynamic and static compliance and so on.
次要结局
- systemic inflammatory response(Period from 48 hours before surgery to 12 hours after ICU)
研究者
WeiPing Cheng
Professor;Chief Physician
Beijing Anzhen Hospital
