Mechanism and Early Intervention Research on ALI During Emergence Surgery of Acute Stanford A Aortic Dissection
|ClinicalTrials.gov Identifier: NCT01894334|
Recruitment Status : Unknown
Verified January 2014 by WeiPing Cheng, Beijing Anzhen Hospital.
Recruitment status was: Active, not recruiting
First Posted : July 10, 2013
Last Update Posted : January 24, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Aortic Dissection||Drug: Ulinastatin Drug: Tranexamic acid Drug: Edaravone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Mechanism and Early Intervention Research on Acute Lung Injury During Emergence Surgery of Acute Stanford A Aortic Dissection|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||January 2015|
No Intervention: Control group
Experimental: Tranexamic acid group
tranexamic acid ，intravenous 30mg/kg/d，Preoperative
|Drug: Tranexamic acid|
Experimental: Edaravone group
edaravone, iv, 1mg/kg/d,Preoperative
Experimental: Ulinastatin group
Ulinastatin ,iv，20,000 U /kg/d，Preoperative
- perioperative outcome and improve of ALI [ Time Frame: Period from 48 hours before surgery to 12 hours after ICU ]
- 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.
- systemic inflammatory response [ Time Frame: Period from 48 hours before surgery to 12 hours after ICU ]
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894334
|Principal Investigator:||WeiPing Cheng, master||Chief Physician，Professor|