Clinical trial NCT01894334: Mechanism and Early Intervention Research on ALI During Emergence Surgery of Acute Stanford A Aortic Dissection
Official title: Mechanism and Early Intervention Research on Acute Lung Injury During Emergence Surgery of Acute Stanford A Aortic Dissection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Aortic Dissection
Keywords: Aortic dissection
acute lung injury
injury mechanism
early intervention
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.


Eligibility criteria: 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

Primary outcomes:
measure: perioperative outcome and improve of ALI
timeFrame: Period from 48 hours before surgery to 12 hours after ICU
Secondary outcomes:
measure: systemic inflammatory response
timeFrame: Period from 48 hours before surgery to 12 hours after ICU
Other outcomes:
Locations:
Study officials:
affiliation: Chief Physician，Professor
name: WeiPing Cheng, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gao Z, Pei X, He C, Wang Y, Lu J, Jin M, Cheng W. Oxygenation impairment in patients with acute aortic dissection is associated with disorders of coagulation and fibrinolysis: a prospective observational study. J Thorac Dis. 2019 Apr;11(4):1190-1201. doi: 10.21037/jtd.2019.04.32.
citation: Pan X, Lu J, Cheng W, Yang Y, Zhu J, Jin M. Independent factors related to preoperative acute lung injury in 130 adults undergoing Stanford type-A acute aortic dissection surgery: a single-center cross-sectional clinical study. J Thorac Dis. 2018 Jul;10(7):4413-4423. doi: 10.21037/jtd.2018.06.140.
citation: Cheng Y, Jin M, Dong X, Sun L, Liu J, Wang R, Yang Y, Lin P, Hou S, Ma Y, Wang Y, Pan X, Lu J, Cheng W. Mechanism and early intervention research on ALI during emergence surgery of Stanford type-A AAD: Study protocol for a prospective, double-blind, clinical trial. Medicine (Baltimore). 2016 Oct;95(42):e5164. doi: 10.1097/MD.0000000000005164.