Type A Aortic DissectionPhase 4STOPNCT07156656
Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection
A Phase 4 study testing Conventional treatment and Sivelestat sodium in people with Type A Aortic Dissection and Organ Failure, Multiple, run by Shanghai Zhongshan Hospital at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type A Aortic Dissection, Organ Failure, Multiple
- What is being tested?
- Conventional treatment and Sivelestat sodium
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 6 sitesChina
- Study dates
- 1 Sep 2025to 30 Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years inclusive.
- Written informed consent obtained before participation.
- Confirmed acute Stanford type A aortic dissection scheduled for surgical repair.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Fujian Provincial Hospital
Fuzhou, Fujian
Han Chen, 86 + 18695770932
Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) (Guangdong Provincial People's Hospital Affiliated to Southern Medical University)
Guangzhou, Guangdong
Liming Lei, 86 + 18688906579
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Qian Gong, 86 + 18226616000
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality
Bailing Li, 86 + 13601973040
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong
Peijun Li, 86 + 18002093166
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi
Tao Shi, 86 + 13891881699
About this study
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
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.
Read more
Participants will:
- Take drug Siv or the placebo through vein continuously for 72 hours
- Receiving regular intensive care in ICU after the operation
- Conditions
- Type A Aortic Dissection, Organ Failure, Multiple
- Being tested
- Conventional treatment, Sivelestat sodium, Placebo
- Keywords
- Type A Aortic Dissection, SOFA, Sivelestat Sodium, Multiple Organ Failure
- Medical subject headings
- Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional treatmentProcedure or surgery
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 sodiumDrug
Also called Siv
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sivelestat group | Experimental | Drug: Sivelestat Sodium. Procedure: Conventional Treatment Receives: Procedure: Conventional treatment; Drug: Sivelestat sodium |
| Control group | Placebo comparator | Drug: Placebo. Procedure: Conventional Treatment Receives: Procedure: Conventional treatment; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the first dose)
Secondary outcomes (44)
AUC - SOFA
Area under the SOFA-time curve
Measured: 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
Incidence of tracheotomy
Measured: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Clinical Outcomes - Re-intubation rate
Re-intubation rate
Measured: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Clinical Outcomes - Gastrointestinal bleeding （count, rate）
Gastrointestinal bleeding （count, rate）
Measured: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Clinical Outcomes - Infection
Infection: Serious infections such as bloodstream infections, sepsis, ventilator-associated pneumonia
Measured: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Clinical Outcomes - In-hospital mortality
In-hospital mortality
Measured: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Clinical Outcomes - ICU length of stay (days)
ICU length of stay (days)
Measured: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Clinical Outcomes - Total hospital length of stay (days)
Total hospital length of stay (days)
Measured: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Clinical Outcomes - Ventilator-free days at day 28 (days)
Mechanical ventilation includes: invasive mechanical ventilation and non-invasive mechanical ventilation
Measured: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Clinical Outcomes - Invasive ventilatory support duration at day 28 (days)
Invasive ventilatory support: invasive mechanical ventilation
Measured: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Clinical Outcomes - Respiratory-support-free time at day 28 (days)
Respiratory support includes: invasive mechanical ventilation, non-invasive mechanical ventilation, and high-flow oxygen
Measured: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Clinical Outcomes - Organ-support-free days at day 28(days)
days free of mechanical ventilation, vasopressors, and renal-replacement therapy
Measured: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Clinical Outcomes - Central nervous system complications during ICU stay
Central nervous system complications during ICU stay: cerebral infarction, intracranial hemorrhage, hypoxic-ischemic encephalopathy
Measured: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Clinical Outcomes - Delirium incidence during ICU stay
Delirium incidence during ICU stay
Measured: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Clinical Outcomes - Incidence of acute kidney injury (AKI)
Incidence of acute kidney injury (AKI)
Measured: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Laboratory Test Results - Arterial blood gas: pH
pH result from arterial blood gas
Measured: 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
PaO₂/FiO₂ result from arterial blood gas
Measured: 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
SpO₂/FiO₂ result from arterial blood gas
Measured: 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
PaO₂ result from arterial blood gas
Measured: 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
PaCO₂ result from arterial blood gas
Measured: 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
SpO₂ result from arterial blood gas
Measured: 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
lactate result from arterial blood gas
Measured: 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
AST from Liver \& kidney function
Measured: 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
ALT from Liver \& kidney function
Measured: 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
ALP from Liver \& kidney function
Measured: 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
GGT from Liver \& kidney function
Measured: 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
TBil from Liver \& kidney function
Measured: 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
DBIL from Liver \& kidney function
Measured: 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
ALB from Liver \& kidney function
Measured: 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
Scr from Liver \& kidney function
Measured: 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
BUN from Liver \& kidney function
Measured: 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
eGFR from Liver \& kidney function
Measured: 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
NGAL from Liver \& kidney function
Measured: 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
CK-MB from Myocardial injury
Measured: 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
LDH from Myocardial injury
Measured: 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
cTnI or cTnT from Myocardial injury
Measured: 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
BNP or NT-proBNP from Myocardial injury
Measured: 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
NSE result from blood test, Brain injury part
Measured: 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
CRP result from Inflammation test
Measured: 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
PCT result from Inflammation test
Measured: 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
IL-6 result from Inflammation test8
Measured: 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
IL-8 result from Inflammation test
Measured: 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
IL-10 result from Inflammation test
Measured: 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
TNF-α result from Inflammation test
Measured: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type A Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a Multicenter, Double-blind RCT
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Zhe Luo, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156656
- Sponsor's protocol ID
- B2025-349R
- Acronym
- STOP
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07156656
- Acronym / sponsor ID
- STOP / B2025-349R
- Conditions
- Type A Aortic Dissection, Organ Failure, Multiple
- Keywords
- Type A Aortic Dissection, SOFA, Sivelestat Sodium, Multiple Organ Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- 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
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- a Multicenter, Double-blind RCT
| Arm | Type | Receives |
|---|---|---|
| Sivelestat group | Experimental | Procedure: Conventional treatment, Drug: Sivelestat sodiumDrug: Sivelestat Sodium. Procedure: Conventional Treatment |
| Control group | Placebo comparator | Procedure: Conventional treatment, Drug: PlaceboDrug: Placebo. Procedure: Conventional Treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75 years inclusive.
- Written informed consent obtained before participation.
- Confirmed acute Stanford type A aortic dissection scheduled for surgical repair.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional treatmentBeside the using of Sivelestat Sodium or placebo, all postoperative care will adhere to each center's standard protocols for type A aortic dissection. | Procedure or surgery | Control group, Sivelestat group |
| Sivelestat sodiumAlso: SivThe 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 | Sivelestat group |
| PlaceboAn 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. | Drug | Control group |
Primary outcome
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.
44 secondary outcomes
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
Clinical Outcomes - Central nervous system complications during ICU stay
Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Clinical Outcomes - Delirium incidence during ICU stay
Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Clinical Outcomes - Incidence of acute kidney injury (AKI)
Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Laboratory Test Results - Arterial blood gas: pH
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhe Luo study chair
Fudan University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conventional treatment and Sivelestat sodium in people with Type A Aortic Dissection and Organ Failure, Multiple, run by Shanghai Zhongshan Hospital at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guowei Tu (86 + 13501996995, tu.guowei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ΔSOFA5 (time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the first dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.