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Not yet recruitingNCT07156656STOPUpdated Sep 5, 2025

Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection

A Phase 4 interventional study of Conventional treatment and Sivelestat sodium in Type A Aortic Dissection and Organ Failure, Multiple, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting at 6 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-05.

Sponsored by Shanghai Zhongshan Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
236
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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
02

Conditions studied

  • Type A Aortic Dissection
  • Organ Failure, Multiple

Keywords

  • Type A Aortic Dissection
  • SOFA
  • Sivelestat Sodium
  • Multiple Organ Failure
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18-75 years inclusive.
  2. Written informed consent obtained before participation.
  3. Confirmed acute Stanford type A aortic dissection scheduled for surgical repair.

Exclusion criteria

Exclusion Criteria:

  1. Life expectancy ≤ 48 hours.
  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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
236 participants (estimated)

Study arms

  • Experimental
    Sivelestat group

    Drug: Sivelestat Sodium. Procedure: Conventional Treatment

    Procedure: Conventional treatment · Drug: Sivelestat sodium

  • Placebo comparator
    Control group

    Drug: Placebo. Procedure: Conventional Treatment

    Procedure: Conventional treatment · Drug: Placebo

Interventions

  • ProcedureConventional 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.

  • DrugSivelestat 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.

    Also known as: Siv

  • DrugPlacebo

    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.

05

What researchers measure

Primary outcomes

  1. ΔSOFA5

    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.

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

Secondary outcomes

  1. AUC - SOFA

    Area under the SOFA-time curve

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

  2. Clinical Outcomes - Incidence of tracheotomy

    Incidence of tracheotomy

    Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

  3. Clinical Outcomes - Re-intubation rate

    Re-intubation rate

    Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

  4. Clinical Outcomes - Gastrointestinal bleeding （count, rate）

    Gastrointestinal bleeding （count, rate）

    Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

  5. Clinical Outcomes - Infection

    Infection: Serious infections such as bloodstream infections, sepsis, ventilator-associated pneumonia

    Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

  6. Clinical Outcomes - In-hospital mortality

    In-hospital mortality

    Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

  7. Clinical Outcomes - ICU length of stay (days)

    ICU length of stay (days)

    Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

  8. Clinical Outcomes - Total hospital length of stay (days)

    Total hospital length of stay (days)

    Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

  9. Clinical Outcomes - Ventilator-free days at day 28 (days)

    Mechanical ventilation includes: invasive mechanical ventilation and non-invasive mechanical ventilation

    Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

  10. Clinical Outcomes - Invasive ventilatory support duration at day 28 (days)

    Invasive ventilatory support: invasive mechanical ventilation

    Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

  11. Clinical Outcomes - Respiratory-support-free time at day 28 (days)

    Respiratory support includes: invasive mechanical ventilation, non-invasive mechanical ventilation, and high-flow oxygen

    Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

  12. Clinical Outcomes - Organ-support-free days at day 28(days)

    days free of mechanical ventilation, vasopressors, and renal-replacement therapy

    Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

  13. Clinical Outcomes - Central nervous system complications during ICU stay

    Central nervous system complications during ICU stay: cerebral infarction, intracranial hemorrhage, hypoxic-ischemic encephalopathy

    Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

  14. Clinical Outcomes - Delirium incidence during ICU stay

    Delirium incidence during ICU stay

    Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

  15. Clinical Outcomes - Incidence of acute kidney injury (AKI)

    Incidence of acute kidney injury (AKI)

    Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

  16. Laboratory Test Results - Arterial blood gas: pH

    pH result from arterial blood gas

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  17. Laboratory Test Results - Arterial blood gas: PaO₂/FiO₂

    PaO₂/FiO₂ result from arterial blood gas

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  18. Laboratory Test Results - Arterial blood gas: SpO₂/FiO₂

    SpO₂/FiO₂ result from arterial blood gas

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  19. Laboratory Test Results - Arterial blood gas: PaO₂

    PaO₂ result from arterial blood gas

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  20. Laboratory Test Results - Arterial blood gas: PaCO₂

    PaCO₂ result from arterial blood gas

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  21. Laboratory Test Results - Arterial blood gas: SpO₂

    SpO₂ result from arterial blood gas

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  22. Laboratory Test Results - Arterial blood gas: lactate

    lactate result from arterial blood gas

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  23. Laboratory Test Results - Liver & kidney function: AST

    AST from Liver \& kidney function

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  24. Laboratory Test Results - Liver & kidney function: ALT

    ALT from Liver \& kidney function

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  25. Laboratory Test Results - Liver & kidney function: ALP

    ALP from Liver \& kidney function

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  26. Laboratory Test Results - Liver & kidney function: GGT

    GGT from Liver \& kidney function

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  27. Laboratory Test Results - Liver & kidney function: TBil

    TBil from Liver \& kidney function

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  28. Laboratory Test Results - Liver & kidney function: DBIL

    DBIL from Liver \& kidney function

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  29. Laboratory Test Results - Liver & kidney function: ALB

    ALB from Liver \& kidney function

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  30. Laboratory Test Results - Liver & kidney function: Scr

    Scr from Liver \& kidney function

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  31. Laboratory Test Results - Liver & kidney function: BUN

    BUN from Liver \& kidney function

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  32. Laboratory Test Results - Liver & kidney function: eGFR

    eGFR from Liver \& kidney function

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  33. Laboratory Test Results - Liver & kidney function: NGAL

    NGAL from Liver \& kidney function

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  34. Laboratory Test Results - Myocardial injury: CK-MB

    CK-MB from Myocardial injury

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  35. Laboratory Test Results - Myocardial injury: LDH

    LDH from Myocardial injury

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  36. Laboratory Test Results - Myocardial injury: cTnI or cTnT

    cTnI or cTnT from Myocardial injury

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  37. Laboratory Test Results - Myocardial injury: BNP or NT-proBNP

    BNP or NT-proBNP from Myocardial injury

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  38. Laboratory Test Results - Brain injury: NSE

    NSE result from blood test, Brain injury part

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  39. Laboratory Test Results - Inflammation: CRP

    CRP result from Inflammation test

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  40. Laboratory Test Results - Inflammation: PCT

    PCT result from Inflammation test

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  41. Laboratory Test Results - Inflammation: IL-6

    IL-6 result from Inflammation test8

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  42. Laboratory Test Results - Inflammation: IL-8

    IL-8 result from Inflammation test

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  43. Laboratory Test Results - Inflammation: IL-10

    IL-10 result from Inflammation test

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

  44. Laboratory Test Results - Inflammation: TNF-α

    TNF-α result from Inflammation test

    Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)

Other outcomes

  1. Plasma neutrophil elastase levels (exploratory outcome)

    Plasma concentration of neutrophil elastase at 1day, 3day and 5day after the first dose in 40 participants enrolled at the main center (20 per arm).

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

06

Study locations

6 sites
  • The First Affiliated Hospital of Anhui Medical University
    Hefei, Anhui, China
    • Qian Gong · Contact · 86 + 18226616000
  • Fujian Provincial Hospital
    Fuzhou, Fujian, China
    • Han Chen · Contact · 86 + 18695770932
  • Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) (Guangdong Provincial People's Hospital Affiliated to Southern Medical University)
    Guangzhou, Guangdong, China
    • Liming Lei · Contact · 86 + 18688906579
  • The University of Hong Kong - Shenzhen Hospital
    Shenzhen, Guangdong, China
    • Peijun Li · Contact · 86 + 18002093166
  • The First Affiliated Hospital of Xi'an Jiao Tong University
    Xi'an, Shaanxi, China
    • Tao Shi · Contact · 86 + 13891881699
  • Changhai Hospital of Shanghai
    Shanghai, Shanghai Municipality, China
    • Bailing Li · Contact · 86 + 13601973040
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07156656
Lead sponsor
Shanghai Zhongshan Hospital
Collaborators
The First Affiliated Hospital of Anhui Medical University, Fujian Provincial Hospital, The University of Hong Kong-Shenzhen Hospital, First Affiliated Hospital Xi'an Jiaotong University, Guangdong Provincial People's Hospital, Changhai Hospital
Responsible party
Sponsor
First posted
Sep 5, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Sep 30, 2028 (estimated)
Completion
Sep 30, 2028 (estimated)
Last update
Sep 5, 2025

Study contacts

Guowei Tu
Contact
tu.guowei@zs-hospital.sh.cn
86 + 13501996995
Chenxu Lin
Contact
chenxu_lin@163.com
86 + 18016402139
Zhe Luo
study chair · Fudan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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