Treatment of ARDS With Sivelestat Sodium

Last updated: April 28, 2025
Sponsor: Sichuan Provincial People's Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Lung Injury

Respiratory Failure

Acute Respiratory Distress Syndrome (Ards)

Treatment

Saline

Sivelestat sodium

Clinical Study ID

NCT04909697
SichuanPPHospital
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Males and females > 18 years old and <75 years old (non-pregnant, non-lactatingfemales).

  2. Patients fulfilled the Berlin diagnostic criteria of acute respiratory distresssyndrome, with a arterial oxygen partial pressure (PaO2) to fraction of inspiredoxygen (FiO2) between 150 mmHg and 300 mmHg.

  3. Signed written informed consent has been obtained

Exclusion

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 doctorin charge

  5. ARDS course>3 days

  6. Agranulocytosis or receiving immunosuppressive agents or high doses ofcorticosteroids (methylprednisolone>40mg/day)

  7. Pregnancy or breastfeeding

  8. Participated in this study

  9. Do not agree to participate in this experiment

Study Design

Total Participants: 324
Treatment Group(s): 2
Primary Treatment: Saline
Phase: 4
Study Start date:
April 18, 2022
Estimated Completion Date:
March 30, 2026

Connect with a study center

  • Sichuan provincial people's hospital

    Chengdu, Sichuan Privince
    China

    Active - Recruiting

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