Neutrophil elastase (NE) released by neutrophils play an important role in inflammatory cascade and lung tissue injury of ARDS.Inhibition of NE is expected to prevent the pathophysiological process of ARDS and alleviate lung injury. Siverestat sodium is a specific inhibitor of NE, which has been proved by basic and observational clinical studies to be effective in alleviating lung injury of ARDS, but there is a lack of prospective multi-center randomized controlled clinical trials.Therefore, this study was intended to evaluate the efficacy of sivelestat sodium in the treatment of ARDS patients with SIRS in a multicenter randomized controlled clinical trial
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
324
4.8mg/kg sivelestat sodium was given in 50ml normal saline, and was continuously pumped in the dark for 24h, equivalent to 0.2mg/kg/h.Applied for 5 consecutive days
50ml normal saline was continuously pumped in the dark for 24h. Applied for 5 consecutive days
Sichuan provincial people's hospital
Chengdu, Sichuan Privince, China
oxygenation improvement rate
Time frame: day 3
28-day ventilator-free days
The 28-day VFDs is defined as the number of study days that the patient is alive and off mechanical ventilation after successful weaning. If a patient dies within 28 days, the VFD is recorded as 0.
Time frame: day 28
Invasive mechanical ventilation rate
Time frame: day 28
length of stay in ICU
Time frame: day 28
length of stay in hospital
Time frame: day 28
28 days mortality
Time frame: day 28
ICU mortality
Time frame: day 28
Incidence of acquired infections
Time frame: day 28
oxygenation improvement rate
Time frame: day 1
oxygenation improvement rate
Time frame: day 5
incidence of severe adverse effect
Time frame: day 28
activity of neutrophil elastase in plasma
Time frame: day0
activity of neutrophil elastase in plasma
Time frame: day 1
activity of neutrophil elastase in plasma
Time frame: day 3
activity of neutrophil elastase in plasma
Time frame: day 5
concentration of IL-6
Time frame: day 0
concentration of IL-6
Time frame: day 1
concentration of IL-6
Time frame: day 3
concentration of IL-6
Time frame: day 5
concentration of IL-10
Time frame: day 0
concentration of IL-10
Time frame: day 1
concentration of IL-10
Time frame: day 3
concentration of IL-10
Time frame: day 5
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