Skip to main content
OpenTrials
Completed

NCT Number: NCT04909697

Treatment of ARDS With Sivelestat Sodium

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sichuan provincial people's hospital

Chengdu, Sichuan Privince, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sivelestat sodium

Drug

4.8mg/kg sivelestat sodium was given in 50ml normal saline, and was continuously pumped in the dark for 24h, equivalent to 0.2mg/kg/h.Applied for 5 consecutive days

Saline

Drug

50ml normal saline was continuously pumped in the dark for 24h. Applied for 5 consecutive days

Primary outcomes

  1. oxygenation improvement rate

    Time frame: day 3

Secondary outcomes

  1. 28-day ventilator-free days

    Time frame: day 28

    The 28-day VFDs is defined as the number of study days that the patient is alive and off mechanical ventilation after successful weaning. If a patient dies within 28 days, the VFD is recorded as 0.

  2. Invasive mechanical ventilation rate

    Time frame: day 28

  3. length of stay in ICU

    Time frame: day 28

  4. length of stay in hospital

    Time frame: day 28

  5. 28 days mortality

    Time frame: day 28

  6. ICU mortality

    Time frame: day 28

  7. Incidence of acquired infections

    Time frame: day 28

  8. oxygenation improvement rate

    Time frame: day 1

  9. oxygenation improvement rate

    Time frame: day 5

  10. incidence of severe adverse effect

    Time frame: day 28

  11. activity of neutrophil elastase in plasma

    Time frame: day0

  12. activity of neutrophil elastase in plasma

    Time frame: day 1

  13. activity of neutrophil elastase in plasma

    Time frame: day 3

  14. activity of neutrophil elastase in plasma

    Time frame: day 5

  15. concentration of IL-6

    Time frame: day 0

  16. concentration of IL-6

    Time frame: day 1

  17. concentration of IL-6

    Time frame: day 3

  18. concentration of IL-6

    Time frame: day 5

  19. concentration of IL-10

    Time frame: day 0

  20. concentration of IL-10

    Time frame: day 1

  21. concentration of IL-10

    Time frame: day 3

  22. concentration of IL-10

    Time frame: day 5

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Registry information

Official study title

Efficacy of Sivelestat Sodium in the Treatment of ARDS With SIRS, a Multicenter Double-blind Randomized Controlled Clinical Trial

Acronym: TOAWSS

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 2, 2021
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.