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

NCT01894334 | Unknown DMC

• 1 other identifier: 2011-2006-03
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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. 1.hemodynamic changes (aortic dissection resulting in acute aortic regurgitation, cardiac tamponade and proximal high blood pressure)
2. 2.ischemia - reperfusion injury of aortic dissection distal organ
3. 3.Aortic intima-media exposure cause coagulation / fibrinolytic system function disorder
4. 4.systemic inflammatory response syndrome; use relevant clinical radiographic parameters, indicators of respiratory mechanics (oxygenation index and lung injury index) and biochemical indicators.

Conditions

Acute Aortic Dissection

Keywords

Aortic dissection; acute lung injury; injury mechanism; early intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• systemic inflammatory response

  Period from 48 hours before surgery to 12 hours after ICU

Study Arms (4)

Control group

NO INTERVENTION

no intervention

Tranexamic acid group

EXPERIMENTAL

tranexamic acid ，intravenous 30mg/kg/d，Preoperative

Drug: Tranexamic acid

Edaravone group

EXPERIMENTAL

edaravone, iv, 1mg/kg/d,Preoperative

Drug: Edaravone

Ulinastatin group

EXPERIMENTAL

Ulinastatin ,iv，20,000 U /kg/d，Preoperative

Drug: Ulinastatin

Interventions

Ulinastatin DRUG

Ulinastatin group

Tranexamic acid DRUG

Tranexamic acid group

Edaravone DRUG

Edaravone group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AAD patients within 48 hrs of onset who are prepared for aortic surgery
• Age between 18 and 70
• Willing to sign the informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Related Publications (3)

• 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.

  PMID: 31179061 DERIVED

• 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.

  PMID: 30174890 DERIVED

• 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.

  PMID: 27759648 DERIVED

MeSH Terms

Conditions

Aortic Dissection; Acute Lung Injury

Interventions

urinastatin; Tranexamic Acid; Edaravone

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Antipyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• WeiPing Cheng, master

  Chief Physician，Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor；Chief Physician

Study Record Dates

• First Submitted: June 8, 2013
• First Posted: July 10, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 24, 2014

Record last verified: 2014-01