Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital

About this trial

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

Qualifiers

Age 18-75 years inclusive.

Written informed consent obtained before participation.

Confirmed acute Stanford type A aortic dissection scheduled for surgical repair.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Conventional treatment
  • Sivelestat sodium
  • Placebo

Treatment groups

236 Participants
are divided into 2 treatment groups

Locations

6
The First Affiliated Hospital of Anhui Medical University HefeiAnhui, China
Fujian Provincial Hospital FuzhouFujian, China
Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) (Guangdong Provincial People's Hospital Affiliated to Southern Medical University) GuangzhouGuangdong, China
The University of Hong Kong - Shenzhen Hospital ShenzhenGuangdong, China

Sponsors and collaborators

Shanghai Zhongshan Hospital

Lead sponsor

The First Affiliated Hospital of Anhui Medical University

Collaborator

Fujian Provincial Hospital

Collaborator

The University of Hong Kong-Shenzhen Hospital

Collaborator

First Affiliated Hospital Xi'an Jiaotong University

Collaborator

Guangdong Provincial People's Hospital

Collaborator

Changhai Hospital

Collaborator