Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection (NCT07156656) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection
China236 participantsStarted 2025-09-01
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 18-75 years inclusive.
✓. Written informed consent obtained before participation.
✓. Confirmed acute Stanford type A aortic dissection scheduled for surgical repair.
Exclusion criteria
✕. Life expectancy ≤ 48 hours.
✕. Pregnant or lactation.
✕. Severe pre-operative liver dysfunction: Child-Turcotte-Pugh score 10-15.
✕. Severe pre-operative renal dysfunction: acute or chronic kidney injury meeting criteria for renal-replacement therapy.
✕. Confirmed COPD or asthma.
✕. Immunosuppression: long-term or \> 2 weeks continuous systemic corticosteroids.
✕. Concomitant or anticipated use of immunomodulators (Xue-Bi-Jing injection, thymosin, IVIG).
What they're measuring
1
ΔSOFA5
Timeframe: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the first dose)