Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection
NCT ID: NCT07156656
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
236 participants
INTERVENTIONAL
2025-09-01
2028-09-30
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sivelestat group
Drug: Sivelestat Sodium. Procedure: Conventional Treatment
Conventional treatment
Beside the using of Sivelestat Sodium or placebo, all postoperative care will adhere to each center's standard protocols for type A aortic dissection.
Sivelestat sodium
The daily dose (4.8 mg/kg) is diluted in 48 mL of 0.9 % saline and administered as a continuous intravenous infusion over 24 hours at 2 mL/h (equivalent to 0.2 mg/kg/h) for 72 consecutive hours.
Control group
Drug: Placebo. Procedure: Conventional Treatment
Conventional treatment
Beside the using of Sivelestat Sodium or placebo, all postoperative care will adhere to each center's standard protocols for type A aortic dissection.
Placebo
An equal volume of placebo-containing only the excipients of sivelestat sodium and diluted to 48 mL with 0.9 % saline-will be infused at 2 mL/h for 72 consecutive hours.
Interventions
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Conventional treatment
Beside the using of Sivelestat Sodium or placebo, all postoperative care will adhere to each center's standard protocols for type A aortic dissection.
Sivelestat sodium
The daily dose (4.8 mg/kg) is diluted in 48 mL of 0.9 % saline and administered as a continuous intravenous infusion over 24 hours at 2 mL/h (equivalent to 0.2 mg/kg/h) for 72 consecutive hours.
Placebo
An equal volume of placebo-containing only the excipients of sivelestat sodium and diluted to 48 mL with 0.9 % saline-will be infused at 2 mL/h for 72 consecutive hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Written informed consent obtained before participation.
3. Confirmed acute Stanford type A aortic dissection scheduled for surgical repair.
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Anhui Medical University
OTHER
Fujian Provincial Hospital
OTHER
The University of Hong Kong-Shenzhen Hospital
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Guangdong Provincial People's Hospital
OTHER
Changhai Hospital
OTHER
Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Zhe Luo
Role: STUDY_CHAIR
Fudan University
Locations
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) (Guangdong Provincial People's Hospital Affiliated to Southern Medical University)
Guangzhou, Guangdong, China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Qian Gong
Role: primary
Han Chen
Role: primary
Liming Lei
Role: primary
Peijun Li
Role: primary
Tao Shi
Role: primary
Bailing Li
Role: primary
Other Identifiers
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B2025-349R
Identifier Type: -
Identifier Source: org_study_id
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