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

Sponsor

Beijing Anzhen Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01894334

Collaborator

(none)

220

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Jan 1, 2015

Anticipated Study Completion Date :

Jan 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

perioperative outcome and improve of ALI [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.

Secondary Outcome Measures

systemic inflammatory response [Period from 48 hours before surgery to 12 hours after ICU]
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