Treatment of ARDS With Sivelestat Sodium (TOAWSS)

Sichuan Provincial People's Hospital

Status and phase: Enrolling; Phase 4

Conditions: Acute Respiratory Distress Syndrome

Treatments: Drug: Sivelestat sodium; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04909697

SichuanPPHospital

Details and patient eligibility

About

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

Enrollment: 324 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females > 18 years old and <75 years old (non-pregnant, non-lactating females).
2. 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.
3. Signed written informed consent has been obtained

Exclusion criteria

1. History of chronic respiratory disease
2. Single cardiogenic pulmonary edema
3. Apach2 score ≥21 points
4. Complicated with end-stage disease, or poor prognosis judged by the clinical doctor in charge
5. ARDS course>3 days
6. Agranulocytosis or receiving immunosuppressive agents or high doses of corticosteroids (methylprednisolone>40mg/day)
7. Pregnancy or breastfeeding
8. Participated in this study
9. Do not agree to participate in this experiment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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324 participants in 2 patient groups

Saline

Sham Comparator group

Treatment:

Drug: Saline

Sivelestat Sodium

Experimental group

Treatment:

Drug: Sivelestat sodium