Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional treatment, Sivelestat sodium, Placebo.
- Who it may be relevant to
- Registry conditions: Type A Aortic Dissection, Organ Failure, Multiple. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of the Efficacy of Sivelestat Sodium Treatment in Post-operative Organ Dysfunction in Patients With Acute Type A Aortic Dissection (STOP): a Multicenter, Double-blind RCT
Overview
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
Interventions
- Procedure 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. - Drug 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. - Drug 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.
Primary outcome measures
- ΔSOFA5 [Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the first dose)]
Secondary outcome measures (12)
- AUC - SOFA [Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the first dose)]
- Clinical Outcomes - Incidence of tracheotomy [Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
- Clinical Outcomes - Re-intubation rate [Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
- Clinical Outcomes - Gastrointestinal bleeding （count, rate） [Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
- Clinical Outcomes - Infection [Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
- Clinical Outcomes - In-hospital mortality [Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
- Clinical Outcomes - ICU length of stay (days) [Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
- Clinical Outcomes - Total hospital length of stay (days) [Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
- Clinical Outcomes - Ventilator-free days at day 28 (days) [Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
- Clinical Outcomes - Invasive ventilatory support duration at day 28 (days) [Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
- Clinical Outcomes - Respiratory-support-free time at day 28 (days) [Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
- Clinical Outcomes - Organ-support-free days at day 28(days) [Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
Eligibility criteria
Inclusion criteria
- Age 18-75 years inclusive.
- Written informed consent obtained before participation.
- Confirmed acute Stanford type A aortic dissection scheduled for surgical repair.
Exclusion criteria
- 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.
- Confirmed COPD or asthma.
- Immunosuppression: long-term or > 2 weeks continuous systemic corticosteroids.
- Concomitant or anticipated use of immunomodulators (Xue-Bi-Jing injection, thymosin, IVIG).
- Medical or psychological condition that would interfere with study participation, assessment, or outcomes.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 6 centers
- The First Affiliated Hospital of Anhui Medical University — Hefei
- Fujian Provincial Hospital — Fuzhou
- Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) (Guangdong — Guangzhou
- The University of Hong Kong - Shenzhen Hospital — Shenzhen
- The First Affiliated Hospital of Xi'an Jiao Tong University — Xi'an
- Changhai Hospital of Shanghai — Shanghai
Identifiers
NCT: NCT07156656 · B2025-349R