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

Acute Aortic Dissection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01894334
• Other study ID #: 2011-2006-03
• Status: Active, not recruiting
• Phase: N/A
• First received: June 8, 2013
• Last updated: January 23, 2014
• Start date: April 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2014
• Source: Beijing Anzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Aortic Dissection
• Acute Lung Injury

Intervention

Drug:
• Ulinastatin

• Tranexamic acid

• Edaravone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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 -a, Cluster of Differentiation 11 /Cluster of Differentiation 18 , myeloperoxidase) and surface-active substance	Period from 48 hours before surgery to 12 hours after ICU	No