Treatment of ARDS With Sivelestat Sodium
Phase 4
Recruiting
- Conditions
- Acute Respiratory Distress Syndrome
- Interventions
- Drug: Saline
- Registration Number
- NCT04909697
- Lead Sponsor
- Sichuan Provincial People's Hospital
- 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 ARDS and alleviate lung injury. Siverestat sodium is a specific inhibitor of NE, which has been proved by basic and observational clinical studies to be effective in alleviating lung injury of ARDS, but there is a lack of prospective multi-center randomized controlled clinical trials.Therefore, this study was intended to evaluate the efficacy of sivelestat sodium in the treatment of ARDS patients with SIRS in a multicenter randomized controlled clinical trial
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 324
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sivelestat Sodium Sivelestat sodium - Saline Saline -
- Primary Outcome Measures
Name Time Method oxygenation improvement rate day 3 ventilator free days day 28
- Secondary Outcome Measures
Name Time Method concentration of IL-10 day 5 28 days mortality day 28 oxygenation improvement rate day 5 incidence of severe adverse effect day 28 concentration of IL-6 day 5 Incidence of acquired infections day 28 activity of neutrophil elastase in plasma day 5 Invasive mechanical ventilation rate day 28 length of stay in ICU day 28 length of stay in hospital day 28 ICU mortality day 28
Trial Locations
- Locations (1)
Sichuan provincial people's hospital
🇨🇳Chengdu, Sichuan Privince, China