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Clinical Trials/NCT07156656
NCT07156656Not yet recruitingPhase 4

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

Shanghai Zhongshan Hospital6 sites in 1 country236 target enrollmentStarted: September 1, 2025Last updated:
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Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
236
Locations
6
Primary Endpoint
ΔSOFA5
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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-
  • •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.

Arms & Interventions

Sivelestat group

Experimental

Drug: Sivelestat Sodium. Procedure: Conventional Treatment

Intervention: Conventional treatment (Procedure)

Sivelestat group

Experimental

Drug: Sivelestat Sodium. Procedure: Conventional Treatment

Intervention: Sivelestat sodium (Drug)

Control group

Placebo Comparator

Drug: Placebo. Procedure: Conventional Treatment

Intervention: Conventional treatment (Procedure)

Control group

Placebo Comparator

Drug: Placebo. Procedure: Conventional Treatment

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

ΔSOFA5

Time Frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the first dose)

ΔSOFA5 is defined as the decrease level of SOFA(Sequential Organ Failure Assessment) score from baseline to the fifth day. SOFA score ranges from 0\~24, the higher the score, the poorer the functionality of multiple organs.

Secondary Outcomes

  • Clinical Outcomes - Re-intubation rate(from the entry of ICU(baseline, post-operatively) to the 28th day after surgery)
  • Clinical Outcomes - Infection(from the entry of ICU(baseline, post-operatively) to the 28th day after surgery)
  • Clinical Outcomes - In-hospital mortality(from the entry of ICU(baseline, post-operatively) to the 28th day after surgery)
  • Clinical Outcomes - Ventilator-free days at day 28 (days)(from the entry of ICU(baseline, post-operatively) to the 28th day after surgery)
  • AUC - SOFA(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(from the entry of ICU(baseline, post-operatively) to the 28th day after surgery)
  • Clinical Outcomes - Total hospital length of stay (days)(from the entry of ICU(baseline, post-operatively) to the 28th day after surgery)
  • Clinical Outcomes - Invasive ventilatory support duration at day 28 (days)(from the entry of ICU(baseline, post-operatively) to the 28th day after surgery)
  • Clinical Outcomes - Gastrointestinal bleeding （count, rate）(from the entry of ICU(baseline, post-operatively) to the 28th day after surgery)
  • Clinical Outcomes - ICU length of stay (days)(from the entry of ICU(baseline, post-operatively) to the 28th day after surgery)
  • Clinical Outcomes - Respiratory-support-free time at day 28 (days)(from the entry of ICU(baseline, post-operatively) to the 28th day after surgery)
  • Clinical Outcomes - Organ-support-free days at day 28(days)(from the entry of ICU(baseline, post-operatively) to the 28th day after surgery)
  • Clinical Outcomes - Central nervous system complications during ICU stay(from the entry of ICU(baseline, post-operatively) to the 28th day after surgery)
  • Clinical Outcomes - Delirium incidence during ICU stay(from the entry of ICU(baseline, post-operatively) to the 28th day after surgery)
  • Clinical Outcomes - Incidence of acute kidney injury (AKI)(from the entry of ICU(baseline, post-operatively) to the 28th day after surgery)
  • Laboratory Test Results - Arterial blood gas: pH(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Arterial blood gas: PaO₂/FiO₂(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Arterial blood gas: SpO₂/FiO₂(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Arterial blood gas: PaO₂(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Arterial blood gas: PaCO₂(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Arterial blood gas: SpO₂(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Arterial blood gas: lactate(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Liver & kidney function: AST(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Liver & kidney function: ALT(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Liver & kidney function: ALP(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Liver & kidney function: GGT(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Liver & kidney function: TBil(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Liver & kidney function: DBIL(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Liver & kidney function: ALB(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Liver & kidney function: Scr(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Liver & kidney function: BUN(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Liver & kidney function: eGFR(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Liver & kidney function: NGAL(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Myocardial injury: CK-MB(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Myocardial injury: LDH(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Myocardial injury: cTnI or cTnT(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Myocardial injury: BNP or NT-proBNP(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Brain injury: NSE(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Inflammation: CRP(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Inflammation: PCT(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Inflammation: IL-6(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Inflammation: IL-8(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Inflammation: IL-10(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))
  • Laboratory Test Results - Inflammation: TNF-α(from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment))

Investigators

Sponsor
Shanghai Zhongshan Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (6)

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