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Safety and Efficacy of Sivelestat Sodium in the Treatment of ARDS: A Prospective, Multicenter, Real-World Study

Safety and Efficacy of Sivelestat Sodium in the Treatment of ARDS: A Prospective, Multicenter, Real-World Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107626
Enrollment
Unknown
Registered
2025-08-15
Start date
2025-08-15
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory distress syndrome

Interventions

Observation group:Conventional therapy combined with Sivelestat Sodium for Injection
Control Group:Conventional therapy

Sponsors

Wenjiang District People's Hospital, Chengdu
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. 18 years old< = age<=80 years old, gender is not limited; 2. Admission diagnosis of ARDS, ARDS meets the 2023 global new diagnostic criteria (Appendix 1); 3. Sign the informed consent form and fully understand the research content, process and possible adverse reactions;

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women and children; 2. Patients with malignant tumors; 3. Patients with cardiogenic pulmonary edema, patients with pneumothorax, bronchopleural fistula and severe pulmonary fibrosis; 4. Patients who are participating in other exploratory clinical studies at the same time; 5. Expected survival time not more than 5 days; 6. Allergic to the active ingredients of the experimental drug or its excipients; 7. Patients with severe data loss; 8. Patients who are judged by the investigator to be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
PaO2/FiO2;28-day survival rate;

Secondary

MeasureTime frame
C-reactive protein;Procalcitonin;Interleukin-6;Duration of mechanical ventilation (MV duration);ICU length of stay (ICU LOS);

Countries

China

Contacts

Public ContactLuo Linjie

Wenjiang District People's Hospital, Chengdu

124469782@qq.com+86 151 8313 7799

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026