Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection

Launched by SHANGHAI ZHONGSHAN HOSPITAL ·

Keywords

ClinConnect Summary

This is a multicenter, double-blind, randomized trial to find out whether giving sivelestat sodium (Siv) after surgery for acute type A aortic dissection can protect organ function and improve recovery. Adults aged 18–75 with this condition who are planned for surgical repair will be randomly assigned to receive Siv or a placebo for 72 hours, in addition to standard post-operative care. The study plans to enroll about 236 participants at several Chinese centers, and neither the patients nor the care team will know which treatment each person receives.

Participants will have Siv or a placebo infused through a vein for 3 days after surgery. The main question is whether Siv helps organs work better by day 5, measured by the SOFA score (lower is better). They will also look at the overall organ function over the first five days and many other outcomes up to 28 days, including breathing support needs, infections, kidney and liver problems, ICU and hospital length of stay, and survival. The trial has specific exclusion rules (for example, very limited life expectancy, pregnancy, severe liver or kidney disease, COPD, or certain immune conditions). The study is not recruiting yet and is expected to run through 2028, so results are not yet known.

Gender

ALL

Eligibility criteria