Clinical trial NCT04909697: Treatment of ARDS With Sivelestat Sodium
Official title: Efficacy of Sivelestat Sodium in the Treatment of ARDS With SIRS, a Multicenter Double-blind Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Acute Respiratory Distress Syndrome
Keywords: Acute Respiratory Distress Syndrome
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 324
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: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. Males and females \> 18 years old and \<75 years old (non-pregnant, non-lactating females).
2. Patients fulfilled the Berlin diagnostic criteria of acute respiratory distress syndrome, with a arterial oxygen partial pressure (PaO2) to fraction of inspired oxygen (FiO2) between 150 mmHg and 300 mmHg.
3. Signed written informed consent has been obtained

Exclusion Criteria:

1. History of chronic respiratory disease
2. Single cardiogenic pulmonary edema
3. Apach2 score ≥21 points
4. Complicated with end-stage disease, or poor prognosis judged by the clinical doctor in charge
5. ARDS course\>3 days
6. Agranulocytosis or receiving immunosuppressive agents or high doses of corticosteroids (methylprednisolone\>40mg/day)
7. Pregnancy or breastfeeding
8. Participated in this study
9. Do not agree to participate in this experiment

Primary outcomes:
measure: oxygenation improvement rate
timeFrame: day 3
measure: ventilator free days
timeFrame: day 28
Secondary outcomes:
measure: Invasive mechanical ventilation rate
timeFrame: day 28
measure: length of stay in ICU
timeFrame: day 28
measure: length of stay in hospital
timeFrame: day 28
measure: 28 days mortality
timeFrame: day 28
measure: ICU mortality
timeFrame: day 28
measure: Incidence of acquired infections
timeFrame: day 28
measure: oxygenation improvement rate
timeFrame: day 1
measure: oxygenation improvement rate
timeFrame: day 5
measure: incidence of severe adverse effect
timeFrame: day 28
measure: activity of neutrophil elastase in plasma
timeFrame: day0
measure: activity of neutrophil elastase in plasma
timeFrame: day 1
measure: activity of neutrophil elastase in plasma
timeFrame: day 3
measure: activity of neutrophil elastase in plasma
timeFrame: day 5
measure: concentration of IL-6
timeFrame: day 0
measure: concentration of IL-6
timeFrame: day 1
measure: concentration of IL-6
timeFrame: day 3
measure: concentration of IL-6
timeFrame: day 5
measure: concentration of IL-10
timeFrame: day 0
measure: concentration of IL-10
timeFrame: day 1
measure: concentration of IL-10
timeFrame: day 3
measure: concentration of IL-10
timeFrame: day 5
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan provincial people's hospital
state: Sichuan Privince
Study officials:
affiliation: Sichuan Academy of Medical Sciences
name: Xiaobo Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: