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 groupsSponsors 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
Source ClinicalTrials.gov