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临床试验/NCT01894334
NCT01894334Unknown不适用

Mechanism and Early Intervention Research on Acute Lung Injury During Emergence Surgery of Acute Stanford A Aortic Dissection

Beijing Anzhen Hospital0 个研究点目标入组 220 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

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

  1. hemodynamic changes (aortic dissection resulting in acute aortic regurgitation, cardiac tamponade and proximal high blood pressure)
  2. ischemia - reperfusion injury of aortic dissection distal organ
  3. Aortic intima-media exposure cause coagulation / fibrinolytic system function disorder
  4. 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

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

Experimental

tranexamic acid ,intravenous 30mg/kg/d,Preoperative

干预措施: Tranexamic acid (Drug)

Edaravone group

Experimental

edaravone, iv, 1mg/kg/d,Preoperative

干预措施: Edaravone (Drug)

Ulinastatin group

Experimental

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

发起方
Beijing Anzhen Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

WeiPing Cheng

Professor;Chief Physician

Beijing Anzhen Hospital

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