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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
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 8, 2013
    Last Updated
    January 23, 2014
    Sponsor
    Beijing Anzhen Hospital
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    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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