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

January 23, 2014 updated by: WeiPing Cheng, Beijing Anzhen Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Period from 48 hours before surgery to 12 hours after ICU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Period from 48 hours before surgery to 12 hours after ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Investigators

  • Principal Investigator: WeiPing Cheng, master, Chief Physician，Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

June 8, 2013

First Submitted That Met QC Criteria

July 4, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

January 24, 2014

Last Update Submitted That Met QC Criteria

January 23, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-2006-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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