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NCT07156656
Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection
Conditions: Type A Aortic Dissection, Organ Failure, Multiple
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 236
Sponsor: Shanghai Zhongshan Hospital
Location: The First Affiliated Hospital of Anhui Medical University Hefei Anhui
Summary
The goal of this multicenter, double-blind, randomized controlled trial is to learn if sivelestat sodium (Siv) can protect the organ function in patients suffered operation for acute type A aortic dissection. The main questions it aims to answer are:
* Can the 3-day-treatment of Siv enlarge the Day-0-to-Day-5 drop in the organ-health score (SOFA score)?
* Can this treatment significantly shrink the area under the SOFA curve from first dose to Day 5?
* Can this treatment significantly improve the end of patients in 28 days (clinical outcomes)? Researchers will compare drug Siv to a placebo (a look-alike substance that contains no drug) to see if drug Siv works.
Participants will:
* Take drug Siv or the placebo through vein continuously for 72 hours
* Receiving regular intensive care in ICU after the operation
Eligibility Criteria
Inclusion Criteria:
1. Age 18-75 years inclusive.
2. Written informed consent obtained before participation.
3. Confirmed acute Stanford type A aortic dissection scheduled for surgical repair.
Exclusion Criteria:
1. Life expectancy ≤ 48 hours.
2. Pregnant or lactation.
3. Severe pre-operative liver dysfunction: Child-Turcotte-Pugh score 10-15.
4. Severe pre-operative renal dysfunction: acute or chronic kidney injury meeting criteria for renal-replacement therapy.
5. Confirmed COPD or asthma.
6. Immunosuppression: long-term or \> 2 weeks continuous systemic corticosteroids.
7. Concomitant or anticipated use of immunomodulators (Xue-Bi-Jing injection, thymosin, IVIG).
8. Medical or psychological condition that would interfere with study participation, assessment, or outcomes.
Source: ClinicalTrials.gov (NCT07156656). StuddyBuddy aggregates publicly available trial information.