Status:
UNKNOWN
Improvement of Pulmonary Insufficiency After Aortic Dissection With Sivelestat Sodium
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
Aortic Dissection
Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Aortic dissection (AD) is one of the most dangerous cardiovascular emergencies, with rapid onset, rapid progression, high fatality rate, and a variety of life-threatening complications. Acute lung inj...
Detailed Description
The study is a single-center, randomized, open-label, blank-controlled study, and designs to recruit AD perioperative patients admitted to the Cardiovascular Surgery Department of the First Affiliated...
Eligibility Criteria
Inclusion
- Patients aged from 18 to 70 years old;
- Patients undergoing aortic dissection arch surgery under hypothermic circulatory arrest;
- Weight from 45 to 90kg;
- ASA cardiac function class from II to IV;
- Patients who can understand and comply with the requirements of the protocol and volunteer to participate.
Exclusion
- Patients participating in other clinical studies;
- Patients with serious lack of medical data;
- Women who are pregnant or may become pregnant or breastfeeding;
- Patients with severe lung diseases, such as end-stage chronic obstructive pulmonary disease, chronic interstitial lung disease, etc.;
- Patients with malignant tumors;
- Preoperative oxygenation index PaO2/FiO2≤200mmHg;
- Patients with EUROScoreII mortality risk \< 3%;
- Patients with APACHE II score ≥ 21;
- Patients who are judged by the researchers to be unsuitable for inclusion, such as those with mental illnesses.
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT05343338
Start Date
April 20 2022
End Date
December 31 2024
Last Update
April 25 2022
Active Locations (1)
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1
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710061