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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
  Purpose

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 Intervention
Acute Aortic Dissection
Drug: Ulinastatin
Drug: Tranexamic acid
Drug: Edaravone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Beijing Anzhen Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 220
Study Start Date: April 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01894334

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

No publications provided

Responsible Party: WeiPing Cheng, Professor;Chief Physician, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT01894334     History of Changes
Other Study ID Numbers: 2011-2006-03
Study First Received: June 8, 2013
Last Updated: January 23, 2014
Health Authority: China: Beijing Municipal Science and Technology Commission

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

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

ClinicalTrials.gov processed this record on November 24, 2014