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Clinical Trial Summary

Sivelestat sodium has been approved for use in patients with SIRS and ALI, but whether it can protect patients with sepsis from developing ARDS remains unknown.The aim of this study was to determine whether sivelestat sodium has a protective effect on ARDS in patients with sepsis.


Clinical Trial Description

The study was conducted in accordance with good clinical practice and with the guidelines set out in the Declaration of Helsinki. After approval from local and national ethics committees, patients from 3 centers in China were recruited. All patients were randomized, in a double-blind manner, to receive either sivelestat sodium regimen or a placebo regimen for 1- 7 days in ICU. The aim of this study was to determine whether sivelestat sodium has a protective effect on ARDS in patients with sepsis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04973670
Study type Interventional
Source Southeast University, China
Contact Liu ling, MD
Phone +86-25-83262552
Email liulingdoctor@126.com
Status Recruiting
Phase Phase 3
Start date October 11, 2021
Completion date October 30, 2023

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