Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection

Not Applicable

Not yet recruiting

• Conditions: Type A Aortic Dissection; Organ Failure, Multiple
• Interventions: Procedure: Conventional treatment; Drug: Sivelestat sodium; Drug: Placebo

• Registration Number: NCT07156656
• Lead Sponsor: Shanghai Zhongshan Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-20
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study Start: 2025-09-01
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Primary Completion: 2028-09-30
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 236

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sivelestat group	Conventional treatment	Drug: Sivelestat Sodium. Procedure: Conventional Treatment
Sivelestat group	Sivelestat sodium	Drug: Sivelestat Sodium. Procedure: Conventional Treatment
Control group	Conventional treatment	Drug: Placebo. Procedure: Conventional Treatment
Control group	Placebo	Drug: Placebo. Procedure: Conventional Treatment

Primary Outcome Measures

Name	Time	Method
ΔSOFA5	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 Outcome Measures

Name	Time	Method
Clinical Outcomes - Re-intubation rate	from the entry of ICU(baseline, post-operatively) to the 28th day after surgery	Re-intubation rate
Clinical Outcomes - Infection	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	from the entry of ICU(baseline, post-operatively) to the 28th day after surgery	In-hospital mortality
Clinical Outcomes - Ventilator-free days at day 28 (days)	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
AUC - SOFA	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	from the entry of ICU(baseline, post-operatively) to the 28th day after surgery	Incidence of tracheotomy
Clinical Outcomes - Total hospital length of stay (days)	from the entry of ICU(baseline, post-operatively) to the 28th day after surgery	Total hospital length of stay (days)
Clinical Outcomes - Invasive ventilatory support duration at day 28 (days)	from the entry of ICU(baseline, post-operatively) to the 28th day after surgery	Invasive ventilatory support: invasive mechanical ventilation
Clinical Outcomes - Gastrointestinal bleeding （count, rate）	from the entry of ICU(baseline, post-operatively) to the 28th day after surgery	Gastrointestinal bleeding （count, rate）
Clinical Outcomes - ICU length of stay (days)	from the entry of ICU(baseline, post-operatively) to the 28th day after surgery	ICU length of stay (days)
Clinical Outcomes - Respiratory-support-free time at day 28 (days)	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)	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	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	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)	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

Trial Locations

Locations (6)

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Fujian Provincial Hospital; 🇨🇳 Fuzhou, Fujian, China

Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) (Guangdong Provincial People's Hospital Affiliated to Southern Medical University); 🇨🇳 Guangzhou, Guangdong, China

The University of Hong Kong - Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China

The First Affiliated Hospital of Xi'an Jiao Tong University; 🇨🇳 Xi'an, Shaanxi, China

Changhai Hospital of Shanghai; 🇨🇳 Shanghai, Shanghai Municipality, China