Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis

Sponsor

Southeast University, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT04973670

Collaborator

(none)

238

Enrollment

Location

Arms

24.6

Anticipated Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ARDS	Drug: Sivelestat sodium Drug: Placebo	Phase 3

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

Anticipated Enrollment :

238 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 11, 2021

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sivelestat sodium Sivelestat sodium 0.2mg/kg.h	Drug: Sivelestat sodium Sivelestat sodium 0.2mg/kg.h for 1-7 days
Active Comparator: placebo The same amount of NS containing only sivelestat sodium excipients	Drug: Placebo The same amount of NS containing only sivelestat sodium excipients

Arm

Intervention/Treatment

Experimental: Sivelestat sodium

Sivelestat sodium 0.2mg/kg.h

Drug: Sivelestat sodium

Sivelestat sodium 0.2mg/kg.h for 1-7 days

Active Comparator: placebo

The same amount of NS containing only sivelestat sodium excipients

Drug: Placebo

The same amount of NS containing only sivelestat sodium excipients

Outcome Measures

Primary Outcome Measures

Progression to ARDS within 7 days (Berlin criteria) [From study drug administration to days 7]
The proportion of patients with sepsis progressing to ARDS

Secondary Outcome Measures

Oxygenation index (PaO2/FiO2) or SpO2 / FiO2 on day 1, 3 and 7 from drug administration [From study drug administration to days 7]
PaO2/FiO2 or SpO2 / FiO2 was recorded on day 1, 3 and 7 from drug administration
Concentration of inflammatory factors on day 1, 3 and 7 from drug administration [From study drug administration to days 7]
Inflammatory factors include Interleukin(IL)-1β,IL-6, IL-8, IL-10, tumor necrosis factor(TNF)-α
Concentration of neutrophil elastase on day 1, 3 and 7 from drug administration [From study drug administration to days 7]
Concentration of neutrophil elastase was recorded on day 1, 3 and 7 from drug administration
Platelet count on day 1, 3 and 7 from drug administration [From study drug administration to days 7]
Platelet count was recorded on day 1, 3 and 7 from drug administration
Concentration of C-reactive protein on day 1, 3 and 7 from drug administration [From study drug administration to days 7]
Concentration of High sensitivity C-reactive protein was recorded on day 1, 3 and 7 from drug administration
Acute Physiology and Chronic Health Evaluation II (APACHE II) score on day 1, 3 and 7 from drug administration [From study drug administration to days 7]
The APACHE II scores on day 1, 3 and 7 were recorded
The 28-day ventilator-free days (VFD) [From study drug administration to day 28]
Days alive and free from mechanical ventilation from study drug administration to day 28
The 28-day respiratory and cardiovascular organ support-free days [From study drug administration to day 28]
Days alive and free from mechanical ventilation and circulatory support which define as infusion of any vasopressor/inotrope agent for a minimum of 1 hour (i.e.norepinephrine, epinephrine, phenylephrine, vasopressin analogues, angiotensin, dopamine, dobutamine, milrinone or levosimendan) from study drug administration to day 28
The 28-day mortality [From study drug administration to day 28]
Death of any cause from study drug administration to day 28
The 90-day mortality [From study drug administration to day 90]
Death of any cause from study drug administration to day 90

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.