Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis

Southeast University, China

Status and phase: Enrolling; Phase 3

Conditions: ARDS

Treatments: Drug: Placebo; Drug: Sivelestat sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT04973670

ZDHL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 238 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Within 24 hours after admission, sepsis 3.0 diagnostic criteria were met;
• The patients or their family members fully understand the purpose and significance of the trial, voluntarily participate in the clinical trial, and sign the informed consent.

Exclusion criteria

• Patients with ARDS were identified at the time of admission;
• Patients who explicitly refused mechanical ventilation;
• Patients with 3 or more extrapulmonary organ injuries and organ failure(single organ SOFA score ≥ 3);
• Patients who need home oxygen therapy or with home mechanical ventilation (by tracheotomy or noninvasive ventilation, but excluding CPAP / BiPAP, only for patients with obstructive sleep apnea);
• The patient whose expected survival time was less than 48 hours;
• Pregnant women and lactating women;
• Other conditions judged by the researcher not suitable for inclusion.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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238 participants in 2 patient groups

Sivelestat sodium

Experimental group

Description:

Sivelestat sodium 0.2mg/kg.h

Treatment:

Drug: Sivelestat sodium

placebo

Active Comparator group

Description:

The same amount of NS containing only sivelestat sodium excipients

Treatment:

Drug: Placebo