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

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ClinicalTrials.gov Identifier: NCT01894334
Recruitment Status : Unknown
Verified January 2014 by WeiPing Cheng, Beijing Anzhen Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 10, 2013
Last Update Posted : January 24, 2014
Sponsor:
Information provided by (Responsible Party):
WeiPing Cheng, Beijing Anzhen Hospital

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.


Condition or disease Intervention/treatment Phase
Acute Aortic Dissection Drug: Ulinastatin Drug: Tranexamic acid Drug: Edaravone Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mechanism and Early Intervention Research on Acute Lung Injury During Emergence Surgery of Acute Stanford A Aortic Dissection
Study Start Date : April 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2015


Arm Intervention/treatment
No Intervention: Control group
no intervention
Experimental: Tranexamic acid group
tranexamic acid ,intravenous 30mg/kg/d,Preoperative
Drug: Tranexamic acid
Experimental: Edaravone group
edaravone, iv, 1mg/kg/d,Preoperative
Drug: Edaravone
Experimental: Ulinastatin group
Ulinastatin ,iv,20,000 U /kg/d,Preoperative
Drug: Ulinastatin



Primary Outcome Measures :
  1. perioperative outcome and improve of ALI [ Time Frame: Period from 48 hours before surgery to 12 hours after ICU ]

    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 :
  1. systemic inflammatory response [ Time Frame: Period from 48 hours before surgery to 12 hours after ICU ]

    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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894334


Sponsors and Collaborators
Beijing Anzhen Hospital
Investigators
Principal Investigator: WeiPing Cheng, master Chief Physician,Professor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: WeiPing Cheng, Professor;Chief Physician, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT01894334     History of Changes
Other Study ID Numbers: 2011-2006-03
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: January 24, 2014
Last Verified: January 2014

Keywords provided by WeiPing Cheng, Beijing Anzhen Hospital:
Aortic dissection
acute lung injury
injury mechanism
early intervention

Additional relevant MeSH terms:
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Tranexamic Acid
Urinastatin
Phenylmethylpyrazolone
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs