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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
238
Sivelestat sodium 0.2mg/kg.h for 1-7 days
The same amount of NS containing only sivelestat sodium excipients
Nanjing Zhong-Da Hospital, Southeast University
Nanjing, Jiangsu, China
RECRUITINGProgression to ARDS within 7 days (Berlin criteria)
The proportion of patients with sepsis progressing to ARDS
Time frame: From study drug administration to days 7
Oxygenation index (PaO2/FiO2) or SpO2 / FiO2 on day 1, 3 and 7 from drug administration
PaO2/FiO2 or SpO2 / FiO2 was recorded on day 1, 3 and 7 from drug administration
Time frame: From study drug administration to days 7
Concentration of inflammatory factors on day 1, 3 and 7 from drug administration
Inflammatory factors include Interleukin(IL)-1β,IL-6, IL-8, IL-10, tumor necrosis factor(TNF)-α
Time frame: From study drug administration to days 7
Concentration of neutrophil elastase on day 1, 3 and 7 from drug administration
Concentration of neutrophil elastase was recorded on day 1, 3 and 7 from drug administration
Time frame: From study drug administration to days 7
Platelet count on day 1, 3 and 7 from drug administration
Platelet count was recorded on day 1, 3 and 7 from drug administration
Time frame: From study drug administration to days 7
Concentration of C-reactive protein on day 1, 3 and 7 from drug administration
Concentration of High sensitivity C-reactive protein was recorded on day 1, 3 and 7 from drug administration
Time frame: From study drug administration to days 7
Sequential organ failure assessment (SOFA) score on day 1, 3 and 7 from drug administration
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The SOFA scores on day 1, 3 and 7 were recorded
Time frame: From study drug administration to days 7
The 28-day ventilator-free days (VFD)
Days alive and free from mechanical ventilation from study drug administration to day 28
Time frame: From study drug administration to day 28
The 28-day shock-free days
Days alive and free from vasopressor 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
Time frame: From study drug administration to day 28
The 28-day time to clinical improvement
Defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first. The seven-category ordinal scale consisted of the following categories: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and 7, death.
Time frame: From study drug administration to day 28
Length of hospital stay
The number of days the subject stayed in the hospital
Time frame: From administration to discharge hospital, up to 90 days
The 28-day mortality
Death of any cause from study drug administration to day 28
Time frame: From study drug administration to day 28
The 90-day mortality
Death of any cause from study drug administration to day 90
Time frame: From study drug administration to day 90