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Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis

NCT04973670 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2023-04-05

No results posted yet for this study

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.

Conditions

  • ARDS

Interventions

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

Sponsors & Collaborators

  • Southeast University, China

    lead OTHER

Principal Investigators

  • Liu ling, MD · Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-11
Primary Completion
2023-09-30
Completion
2023-10-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04973670 on ClinicalTrials.gov