Clinical trial NCT04973670: Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis
Official title: Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis: Multicenter, Random, Double-blind, Parallel, Placebo Control Clinical Trials
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: ARDS
Keywords: Sepsis
Respiratory Failure
ARDS
efficacy
Sivelestat sodium
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression to ARDS within 7 days (Berlin criteria)
timeFrame: From study drug administration to days 7
Secondary outcomes:
measure: Oxygenation index (PaO2/FiO2) or SpO2 / FiO2 on day 1, 3 and 7 from drug administration
timeFrame: From study drug administration to days 7
measure: Concentration of inflammatory factors on day 1, 3 and 7 from drug administration
timeFrame: From study drug administration to days 7
measure: Concentration of neutrophil elastase on day 1, 3 and 7 from drug administration
timeFrame: From study drug administration to days 7
measure: Platelet count on day 1, 3 and 7 from drug administration
timeFrame: From study drug administration to days 7
measure: Concentration of C-reactive protein on day 1, 3 and 7 from drug administration
timeFrame: From study drug administration to days 7
measure: Sequential organ failure assessment (SOFA) score on day 1, 3 and 7 from drug administration
timeFrame: From study drug administration to days 7
measure: The 28-day ventilator-free days (VFD)
timeFrame: From study drug administration to day 28
measure: The 28-day shock-free days
timeFrame: From study drug administration to day 28
measure: The 28-day time to clinical improvement
timeFrame: From study drug administration to day 28
measure: Length of hospital stay
timeFrame: From administration to discharge hospital, up to 90 days
measure: The 28-day mortality
timeFrame: From study drug administration to day 28
measure: The 90-day mortality
timeFrame: From study drug administration to day 90
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Zhong-Da Hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
name: Liu ling, MD
role: STUDY_CHAIR
References: