NCT04909697

Treatment of ARDS With Sivelestat Sodium

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 324 (estimated)
• Sponsor: Sichuan Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-04-18
• Primary completion: 2026-03-30
• Completion: 2026-03-30
• First posted: 2021-06-02
• Last updated: 2025-05-01

Locations

1 site across 1 country: China