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Cohort Study on the Effectiveness and Safety of Sivelestat Sodium in the Treatment of Respiratory Failure Caused by Community-Acquired Pneumonia

Cohort Study on the Effectiveness and Safety of Sivelestat Sodium in the Treatment of Respiratory Failure Caused by Community-Acquired Pneumonia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500099241
Enrollment
Unknown
Registered
2025-03-20
Start date
2025-03-31
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Respiratory failure caused by community-acquired pneumonia

Interventions

sivelestat Group:none
Control group:none

Sponsors

The First Affiliated Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 18 years old to 80 years old, gender not limited; 2. Patients diagnosed with community-acquired pneumonia accompanied by respiratory failure; 3. In the study group, sivelestat was used within 72 hours after onset of illness; 4. In the study group, sivelestat was used for =5 days.

Exclusion criteria

Exclusion criteria: 1. Other pulmonary diseases (such as hospital-acquired pneumonia, interstitial lung disease, cardiogenic pulmonary edema, pulmonary embolism, bronchiectasis, etc.); 2. Patients with respiratory failure caused by non-pulmonary disease episodes (such as severe malnutrition, chronic heart failure, etc.); 3. Patients with functional failure of three or more extrapulmonary organs; 4. Pregnant or lactating women; 5. Patients with terminal malignant tumors or cachexia; 6. Patients who have been using high-dose hormones (prednisone or equivalent dose >= 1mg/kg/d) for >= 3 weeks continuously; 7. Patients participating in other exploratory clinical studies simultaneously; 8. Patients using drugs with inhibitory effect on elastase such as ulinastatin simultaneously; 9. Patients with severely missing data; 10. Patients judged by the investigators as not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
The improvement situation of respiratory failure ;Clinical improvement ;

Secondary

MeasureTime frame
Mortality rate of respiratory failure;mortality rate;The rate of progression from HFNO/NIV to invasive mechanical ventilation or the rate of conversion from invasive mechanical ventilation to HFNO/NIV;Time without respiratory support;Non-mechanical ventilation time;The rate of secondary intubation;Whether to use CRRT;

Countries

China

Contacts

Public ContactWang Wei

The First Affiliated Hospital of China Medical University

wwbycmu@126.com+86 152 4207 1600

Outcome results

None listed

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