Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

236

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

September 30, 2028

Study Completion Date

September 30, 2028

Conditions
Type A Aortic DissectionOrgan Failure, Multiple
Interventions
PROCEDURE

Conventional 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.

DRUG

Sivelestat 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.

DRUG

Placebo

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.

Trial Locations (6)

Unknown

The First Affiliated Hospital of Anhui Medical University, Hefei

Fujian Provincial Hospital, Fuzhou

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

The University of Hong Kong - Shenzhen Hospital, Shenzhen

The First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an

Changhai Hospital of Shanghai, Shanghai

All Listed Sponsors
collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

collaborator

Fujian Provincial Hospital

OTHER

collaborator

The University of Hong Kong-Shenzhen Hospital

OTHER

collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

collaborator

Guangdong Provincial People's Hospital

OTHER

collaborator

Changhai Hospital

OTHER

lead

Shanghai Zhongshan Hospital

OTHER