Sivelestat treatment to protect organs after surgery for type A aortic dissection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, double-blind, randomized controlled trial in adults undergoing repair for acute Stanford type A aortic dissection. Participants receive either intravenous sivelestat sodium for 72 hours or a placebo, in addition to standard ICU care. The study measures organ function using the SOFA score from day 0 to day 5 and looks at 28-day clinical outcomes. The trial aims to determine whether sivelestat can reduce organ failure and improve recovery compared with placebo. Recruitment involves several hospitals in China and Hong Kong, with strict eligibility criteria to exclude patients with limited life expectancy or significant preoperative organ dysfunction.

Why it matters

Who can join: the full rules

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.

Where it's running

• Changhai Hospital of Shanghai
  Shanghai, Shanghai Municipality, China Recruiting
• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Completed
• Fujian Provincial Hospital
  Fuzhou, Fujian, China Completed
• Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) (Guangdong Provincial People's Hospital Affiliated to Southern Medical University)
  Guangzhou, Guangdong, China Completed
• The University of Hong Kong - Shenzhen Hospital
  Shenzhen, Guangdong, China Completed
• The First Affiliated Hospital of Xi'an Jiao Tong University
  Xi'an, Shaanxi, China Completed

Study contacts

• Study coordinator: Guowei Tu
• Email: tu.guowei@zs-hospital.sh.cn
• Phone: 86 + 13501996995

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.