Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection

• Status: NOT_YET_RECRUITING
• Trial end date: 2028-09-30

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

• Phase: PHASE4

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Changhai Hospital; First Affiliated Hospital Xi'an Jiaotong University; Fujian Provincial Hospital; Guangdong Provincial People's Hospital; The First Affiliated Hospital of Anhui Medical University; The University of Hong Kong-Shenzhen Hospital