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RECRUITING
NCT04909697
PHASE4

Treatment of ARDS With Sivelestat Sodium

Sponsor: Sichuan Provincial People's Hospital

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

324

Start Date

2022-04-18

Completion Date

2026-03-30

Last Updated

2025-05-01

Healthy Volunteers

No

Interventions

DRUG

Sivelestat sodium

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

DRUG

Saline

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

Locations (1)

Sichuan provincial people's hospital

Chengdu, Sichuan Privince, China