Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis: Multicenter, Random, Double-blind, Parallel, Placebo Control Clinical Trials
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 238
- Locations
- 1
- Primary Endpoint
- Progression to ARDS within 7 days (Berlin criteria)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Sivelestat sodium
Sivelestat sodium 0.2mg/kg.h
Intervention: Sivelestat sodium (Drug)
placebo
The same amount of NS containing only sivelestat sodium excipients
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Progression to ARDS within 7 days (Berlin criteria)
Time Frame: From study drug administration to days 7
The proportion of patients with sepsis progressing to ARDS
Secondary Outcomes
- Oxygenation index (PaO2/FiO2) or SpO2 / FiO2 on day 1, 3 and 7 from drug administration(From study drug administration to days 7)
- Concentration of neutrophil elastase on day 1, 3 and 7 from drug administration(From study drug administration to days 7)
- Concentration of C-reactive protein on day 1, 3 and 7 from drug administration(From study drug administration to days 7)
- The 28-day ventilator-free days (VFD)(From study drug administration to day 28)
- Sequential organ failure assessment (SOFA) score on day 1, 3 and 7 from drug administration(From study drug administration to days 7)
- The 28-day mortality(From study drug administration to day 28)
- Concentration of inflammatory factors on day 1, 3 and 7 from drug administration(From study drug administration to days 7)
- Platelet count on day 1, 3 and 7 from drug administration(From study drug administration to days 7)
- The 28-day shock-free days(From study drug administration to day 28)
- The 90-day mortality(From study drug administration to day 90)
- The 28-day time to clinical improvement(From study drug administration to day 28)
- Length of hospital stay(From administration to discharge hospital, up to 90 days)
Investigators
Ling Liu
professor
Southeast University, China