Status:
RECRUITING
Treatment of ARDS With Sivelestat Sodium
Lead Sponsor:
Sichuan Provincial People's Hospital
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Neutrophil elastase (NE) released by neutrophils play an important role in inflammatory cascade and lung tissue injury of ARDS.Inhibition of NE is expected to prevent the pathophysiological process of...
Eligibility Criteria
Inclusion
- Males and females \> 18 years old and \<75 years old (non-pregnant, non-lactating females).
- Patients fulfilled the Berlin diagnostic criteria of acute respiratory distress syndrome, with a arterial oxygen partial pressure (PaO2) to fraction of inspired oxygen (FiO2) between 150 mmHg and 300 mmHg.
- Signed written informed consent has been obtained
Exclusion
- History of chronic respiratory disease
- Single cardiogenic pulmonary edema
- Apach2 score ≥21 points
- Complicated with end-stage disease, or poor prognosis judged by the clinical doctor in charge
- ARDS course\>3 days
- Agranulocytosis or receiving immunosuppressive agents or high doses of corticosteroids (methylprednisolone\>40mg/day)
- Pregnancy or breastfeeding
- Participated in this study
- Do not agree to participate in this experiment
Key Trial Info
Start Date :
April 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT04909697
Start Date
April 18 2022
End Date
March 30 2026
Last Update
May 1 2025
Active Locations (1)
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1
Sichuan provincial people's hospital
Chengdu, Sichuan Privince, China