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Clinical efficacy observation and clinical trial of sivelestat sodium for injection on ARDS patients caused by trauma (except burns)

Clinical efficacy observation and clinical trial of sivelestat sodium for injection on ARDS patients caused by trauma (except burns)

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400091027
Enrollment
Unknown
Registered
2024-10-18
Start date
2023-11-08
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

ARDS caused by trauma (except burns)

Interventions

Cevelestat sodium + conventional treatment group:None
Control group:None

Sponsors

Fourth Medical Center of PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 75 years (inclusive), with no restriction on gender; 2) Definite trauma is needed; 3) Diagnosed with ARDS within 48h using the New Global Definition of ARDS(2023).

Exclusion criteria

Exclusion criteria: 1)Pregnancy or lactatating women; 2)Patients diagnosed with cardiogenic pulmonary edema; 3)Patients diagnosed with chronic lung diseases, including chronic obstructive pulmonary disease (COPD), bronchiectasis, etc; 4)Patients use ulinastatin or xuebijing injection during the study; 5)Patients using glucocorticoids >= 1mg/kg/d within 7 days before included; 6)Patients with 4 or more organ injuries and organ failure or single extra-pulmonary organ SOFA score >= 3; 7)Patients with an APACHE II score>25; 8)Patients diagnosed with malignant tumors, end-stage lung diseases, cachexia, near-death and other end-stage diseases; 9) Patients who refuse to participate or have been included in other trials; 10)Patients judged by the investigator to be unsuitable for this study.

Design outcomes

Primary

MeasureTime frame
Oxygenation index;

Secondary

MeasureTime frame
C-reactive protein content in blood ;Procalcitonin levels in blood ;Interleukin-6 levels in blood ;Interleukin-8 levels in blood ;TNF-a levels in blood ;NEU% in blood;WBC in blood;D-Dimer in blood plasma;Lung compliance;Breathing machine PEEP;28-day survival rate;

Countries

China

Contacts

Public ContactGuo Jianying

Fourth Medical Center of PLA General Hospital

guojy2003@aliyun.com+86 136 7138 1815

Outcome results

None listed

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