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NCT Number: NCT07156656

Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection

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

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Key information

Conditions

Type A Aortic Dissection Multiple Organ Failure Organ Failure, Multiple Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional treatment

Procedure

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

Drug

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.

Other names: Siv

Placebo

Drug

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 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

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)

Area under the SOFA-time curve
Clinical Outcomes - Incidence of tracheotomy

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

Incidence of tracheotomy
Clinical Outcomes - Re-intubation rate

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

Re-intubation rate
Clinical Outcomes - Gastrointestinal bleeding （count, rate）

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

Gastrointestinal bleeding （count, rate）
Clinical Outcomes - Infection

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

Infection: Serious infections such as bloodstream infections, sepsis, ventilator-associated pneumonia
Clinical Outcomes - In-hospital mortality

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

In-hospital mortality
Clinical Outcomes - ICU length of stay (days)

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

ICU length of stay (days)
Clinical Outcomes - Total hospital length of stay (days)

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

Total hospital length of stay (days)
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

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

Invasive ventilatory support: invasive mechanical ventilation
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

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

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

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

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

Delirium incidence during ICU stay
Clinical Outcomes - Incidence of acute kidney injury (AKI)

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

Incidence of acute kidney injury (AKI)
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)

pH result from arterial blood gas
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)

PaO₂/FiO₂ result from arterial blood gas
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)

SpO₂/FiO₂ result from arterial blood gas
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)

PaO₂ result from arterial blood gas
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)

PaCO₂ result from arterial blood gas
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)

SpO₂ result from arterial blood gas
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)

lactate result from arterial blood gas
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)

AST from Liver & kidney function
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)

ALT from Liver & kidney function
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)

ALP from Liver & kidney function
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)

GGT from Liver & kidney function
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)

TBil from Liver & kidney function
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)

DBIL from Liver & kidney function
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)

ALB from Liver & kidney function
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)

Scr from Liver & kidney function
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)

BUN from Liver & kidney function
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)

eGFR from Liver & kidney function
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)

NGAL from Liver & kidney function
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)

CK-MB from Myocardial injury
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)

LDH from Myocardial injury
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)

cTnI or cTnT from Myocardial injury
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)

BNP or NT-proBNP from Myocardial injury
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)

NSE result from blood test, Brain injury part
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)

CRP result from Inflammation test
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)

PCT result from Inflammation test
Laboratory Test Results - Inflammation: IL-6

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

IL-6 result from Inflammation test8
Laboratory Test Results - Inflammation: IL-8

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

IL-8 result from Inflammation test
Laboratory Test Results - Inflammation: IL-10

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

IL-10 result from Inflammation test
Laboratory Test Results - Inflammation: TNF-α

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

TNF-α result from Inflammation test

Other outcomes

Plasma neutrophil elastase levels (exploratory outcome)

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

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).

Study contacts

Contact information is provided by the study sponsor or research team.

Chenxu Lin

CONTACT

[email protected]

86 + 18016402139

Guowei Tu

CONTACT

[email protected]

86 + 13501996995

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

Changhai Hospital
First Affiliated Hospital Xi'an Jiaotong University
Fujian Provincial Hospital
Guangdong Provincial People's Hospital
The First Affiliated Hospital of Anhui Medical University
The University of Hong Kong-Shenzhen Hospital

Registry information

Official study 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

Acronym: STOP

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Sep 5, 2025
Registry last updated: Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Key information

Conditions

Age range

Sex eligibility

Study type

Phase

Primary location

Who can participate

Treatment and study plan

Conventional treatment

Sivelestat sodium

Placebo

Primary outcomes

ΔSOFA5

Secondary outcomes

AUC - SOFA

Clinical Outcomes - Incidence of tracheotomy

Clinical Outcomes - Re-intubation rate

Clinical Outcomes - Gastrointestinal bleeding （count, rate）

Clinical Outcomes - Infection

Clinical Outcomes - In-hospital mortality

Clinical Outcomes - ICU length of stay (days)

Clinical Outcomes - Total hospital length of stay (days)

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

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

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

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

Clinical Outcomes - Central nervous system complications during ICU stay

Clinical Outcomes - Delirium incidence during ICU stay

Clinical Outcomes - Incidence of acute kidney injury (AKI)

Laboratory Test Results - Arterial blood gas: pH

Laboratory Test Results - Arterial blood gas: PaO₂/FiO₂

Laboratory Test Results - Arterial blood gas: SpO₂/FiO₂

Laboratory Test Results - Arterial blood gas: PaO₂

Laboratory Test Results - Arterial blood gas: PaCO₂

Laboratory Test Results - Arterial blood gas: SpO₂

Laboratory Test Results - Arterial blood gas: lactate

Laboratory Test Results - Liver & kidney function: AST

Laboratory Test Results - Liver & kidney function: ALT

Laboratory Test Results - Liver & kidney function: ALP

Laboratory Test Results - Liver & kidney function: GGT

Laboratory Test Results - Liver & kidney function: TBil

Laboratory Test Results - Liver & kidney function: DBIL

Laboratory Test Results - Liver & kidney function: ALB

Laboratory Test Results - Liver & kidney function: Scr

Laboratory Test Results - Liver & kidney function: BUN

Laboratory Test Results - Liver & kidney function: eGFR

Laboratory Test Results - Liver & kidney function: NGAL

Laboratory Test Results - Myocardial injury: CK-MB

Laboratory Test Results - Myocardial injury: LDH

Laboratory Test Results - Myocardial injury: cTnI or cTnT

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

Laboratory Test Results - Brain injury: NSE

Laboratory Test Results - Inflammation: CRP

Laboratory Test Results - Inflammation: PCT

Laboratory Test Results - Inflammation: IL-6

Laboratory Test Results - Inflammation: IL-8

Laboratory Test Results - Inflammation: IL-10

Laboratory Test Results - Inflammation: TNF-α

Other outcomes

Plasma neutrophil elastase levels (exploratory outcome)

Study contacts

Sponsors and collaborators

Lead sponsor

Collaborators

Registry information

Official study title

Important dates

Related clinical trials

Outcomes of Aortic Dissection Repair

Protective Effect of Ulinastatin Against Negative Inflammatory Response and Organ Dysfunction After Acute Type a Aortic Dissection Surgery (PANDA I)

European Registry of Type A Aortic Dissection

Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery