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

Who is this study for? Patients with Acute Respiratory Distress Syndrome
What treatments are being studied? Sivelestat Sodium
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Sichuan provincial people's hospital
RECRUITING
Chengdu
Contact Information
Primary
Hongli He, Ph.D.
hhl0408@163.com
+86-28-87393633
Time Frame
Start Date: 2022-04-18
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 324
Treatments
Sham_comparator: Saline
Experimental: Sivelestat Sodium
Sponsors
Leads: Sichuan Provincial People's Hospital

This content was sourced from clinicaltrials.gov