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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Aortic Dissection

Intervention / Treatment
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* Drug: Ulinastatin
* Drug: Tranexamic acid
* Drug: Edaravone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AAD patients within 48 hrs of onset who are prepared for aortic surgery Age between 18 and 70 Willing to sign the informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>no intervention | |
| Experimental: Tranexamic acid group<br>tranexamic acid ，intravenous 30mg/kg/d，Preoperative | Drug: Tranexamic acid<br> <br> |
| Experimental: Edaravone group<br>edaravone, iv, 1mg/kg/d,Preoperative | Drug: Edaravone<br> <br> |
| Experimental: Ulinastatin group<br>Ulinastatin ,iv，20,000 U /kg/d，Preoperative | Drug: Ulinastatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative outcome and improve of ALI | 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. | Period from 48 hours before surgery to 12 hours after ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systemic inflammatory response | Indicators Lung lavage (immediately after induction of anesthesia、before the end of surgery) determination of imflammatory cytokines (IL-6, IL-8, Tumor Necrosis Factor -α, Cluster of Differentiation 11 /Cluster of Differentiation 18 , myeloperoxidase) and surface-active substance | Period from 48 hours before surgery to 12 hours after ICU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic dissection, acute lung injury, injury mechanism, early intervention