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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
WeiPing Cheng, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier:
NCT01894334
First received: June 8, 2013
Last updated: January 23, 2014
Last verified: January 2014

June 8, 2013
January 23, 2014
April 2013
January 2015   (final data collection date for primary outcome measure)
perioperative outcome and improve of ALI [ Time Frame: Period from 48 hours before surgery to 12 hours after ICU ] [ Designated as safety issue: Yes ]

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.
Same as current
Complete list of historical versions of study NCT01894334 on ClinicalTrials.gov Archive Site
systemic inflammatory response [ Time Frame: Period from 48 hours before surgery to 12 hours after ICU ] [ Designated as safety issue: No ]

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
Same as current
Not Provided
Not Provided
 
Mechanism and Early Intervention Research on ALI During Emergence Surgery of Acute Stanford A Aortic Dissection
Mechanism and Early Intervention Research on Acute Lung Injury During Emergence Surgery of Acute Stanford A Aortic Dissection

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Acute Aortic Dissection
  • Drug: Ulinastatin
  • Drug: Tranexamic acid
  • Drug: Edaravone
  • No Intervention: Control group
    no intervention
  • Experimental: Tranexamic acid group
    tranexamic acid ,intravenous 30mg/kg/d,Preoperative
    Intervention: Drug: Tranexamic acid
  • Experimental: Edaravone group
    edaravone, iv, 1mg/kg/d,Preoperative
    Intervention: Drug: Edaravone
  • Experimental: Ulinastatin group
    Ulinastatin ,iv,20,000 U /kg/d,Preoperative
    Intervention: Drug: Ulinastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
220
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01894334
2011-2006-03
Yes
WeiPing Cheng, Beijing Anzhen Hospital
Beijing Anzhen Hospital
Not Provided
Principal Investigator: WeiPing Cheng, master Chief Physician,Professor
Beijing Anzhen Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP