Mechanism and Early Intervention Research on ALI During Emergence Surgery of Acute Stanford A Aortic Dissection
Primary Purpose
Acute Aortic Dissection
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ulinastatin
Tranexamic acid
Edaravone
Sponsored by
About this trial
This is an interventional prevention trial for Acute Aortic Dissection focused on measuring Aortic dissection, acute lung injury, injury mechanism, early intervention
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Control group
Tranexamic acid group
Edaravone group
Ulinastatin group
Arm Description
no intervention
tranexamic acid ,intravenous 30mg/kg/d,Preoperative
edaravone, iv, 1mg/kg/d,Preoperative
Ulinastatin ,iv,20,000 U /kg/d,Preoperative
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 -α, Cluster of Differentiation 11 /Cluster of Differentiation 18 , myeloperoxidase) and surface-active substance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01894334
Brief Title
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
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Aortic Dissection
Keywords
Aortic dissection, acute lung injury, injury mechanism, early intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
no intervention
Arm Title
Tranexamic acid group
Arm Type
Experimental
Arm Description
tranexamic acid ,intravenous 30mg/kg/d,Preoperative
Arm Title
Edaravone group
Arm Type
Experimental
Arm Description
edaravone, iv, 1mg/kg/d,Preoperative
Arm Title
Ulinastatin group
Arm Type
Experimental
Arm Description
Ulinastatin ,iv,20,000 U /kg/d,Preoperative
Intervention Type
Drug
Intervention Name(s)
Ulinastatin
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Type
Drug
Intervention Name(s)
Edaravone
Primary Outcome Measure Information:
Title
perioperative outcome and improve of ALI
Description
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.
Time Frame
Period from 48 hours before surgery to 12 hours after ICU
Secondary Outcome Measure Information:
Title
systemic inflammatory response
Description
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
Time Frame
Period from 48 hours before surgery to 12 hours after ICU
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WeiPing Cheng, master
Organizational Affiliation
Chief Physician,Professor
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
31179061
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.
Results Reference
derived
PubMed Identifier
30174890
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.
Results Reference
derived
PubMed Identifier
27759648
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.
Results Reference
derived
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Mechanism and Early Intervention Research on ALI During Emergence Surgery of Acute Stanford A Aortic Dissection
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