NCT04973670

Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis

Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis: Multicenter, Random, Double-blind, Parallel, Placebo Control Clinical Trials

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: Southeast University, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• ARDS

Interventions

Type	Name	Description
DRUG	Sivelestat sodium	Sivelestat sodium 0.2mg/kg.h for 1-7 days
DRUG	Placebo	The same amount of NS containing only sivelestat sodium excipients

Timeline

• Start date: 2021-10-11
• Primary completion: 2023-09-30
• Completion: 2023-10-30
• First posted: 2021-07-22
• Last updated: 2023-04-05

Locations

1 site across 1 country: China