Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection

NCT07156656 | Not Yet Recruiting Phase 4

• 1 other identifier: B2025-349R
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 6

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

Conditions

Type A Aortic Dissection; Organ Failure, Multiple

Keywords

Type A Aortic Dissection; SOFA; Sivelestat Sodium; Multiple Organ Failure

Outcome Measures

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.

  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

  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 - Re-intubation rate

  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 - Infection

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

Other Outcomes (1)

• Plasma neutrophil elastase levels (exploratory outcome)

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

Study Arms (2)

Sivelestat group

EXPERIMENTAL

Drug: Sivelestat Sodium. Procedure: Conventional Treatment

Procedure: Conventional treatment; Drug: Sivelestat sodium

Control group

PLACEBO COMPARATOR

Drug: Placebo. Procedure: Conventional Treatment

Procedure: Conventional treatment; Drug: Placebo

Interventions

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.

Control group; Sivelestat group

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.

Also known as: Siv

Sivelestat group

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.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Fujian Provincial Hospital: collaborator
• The University of Hong Kong-Shenzhen Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Changhai Hospital: collaborator

Study Sites (6)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Fujian Provincial Hospital

Fuzhou, Fujian, China

Location

Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) (Guangdong Provincial People's Hospital Affiliated to Southern Medical University)

Guangzhou, Guangdong, China

Location

The University of Hong Kong - Shenzhen Hospital

Shenzhen, Guangdong, China

Location

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, China

Location

Changhai Hospital of Shanghai

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Multiple Organ Failure

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhe Luo

  Fudan University

  STUDY CHAIR

Central Study Contacts

Guowei Tu

CONTACT

86 + 13501996995; tu.guowei@zs-hospital.sh.cn

Chenxu Lin

CONTACT

86 + 18016402139; chenxu_lin@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a Multicenter, Double-blind RCT

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 5, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)