Treatment of ARDS With Sivelestat Sodium (TOAWSS)

  • End date
    Jul 30, 2024
  • participants needed
  • sponsor
    Sichuan Provincial People's Hospital
Updated on 29 April 2022
absolute neutrophil count
acute respiratory distress


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

Condition Acute Respiratory Distress Syndrome
Treatment Saline, Sivelestat sodium
Clinical Study IdentifierNCT04909697
SponsorSichuan Provincial People's Hospital
Last Modified on29 April 2022


Yes No Not Sure

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
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