Treatment of ARDS With Sivelestat Sodium

Study Overview
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Brief Summary
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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

Official Title
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Efficacy of Sivelestat Sodium in the Treatment of ARDS With SIRS, a Multicenter Double-blind Randomized Controlled Clinical Trial

Conditions
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Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Drug: Sivelestat sodium
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females > 18 years old and <75 years old (non-pregnant, non-lactating females). 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. Signed written informed consent has been obtained Exclusion Criteria: History of chronic respiratory disease Single cardiogenic pulmonary edema Apach2 score ≥21 points Complicated with end-stage disease, or poor prognosis judged by the clinical doctor in charge ARDS course>3 days Agranulocytosis or receiving immunosuppressive agents or high doses of corticosteroids (methylprednisolone>40mg/day) Pregnancy or breastfeeding Participated in this study Do not agree to participate in this experiment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Saline<br> | Drug: Saline<br>* 50ml normal saline was continuously pumped in the dark for 24h. Applied for 5 consecutive days<br>|
| Experimental: Sivelestat Sodium<br> | Drug: Sivelestat sodium<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygenation improvement rate |  | day 3 | 
| ventilator free days |  | day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Invasive mechanical ventilation rate |  | day 28 | 
| length of stay in ICU |  | day 28 | 
| length of stay in hospital |  | day 28 | 
| 28 days mortality |  | day 28 | 
| ICU mortality |  | day 28 | 
| Incidence of acquired infections |  | day 28 | 
| oxygenation improvement rate |  | day 1 | 
| oxygenation improvement rate |  | day 5 | 
| incidence of severe adverse effect |  | day 28 | 
| activity of neutrophil elastase in plasma |  | day0 | 
| activity of neutrophil elastase in plasma |  | day 1 | 
| activity of neutrophil elastase in plasma |  | day 3 | 
| activity of neutrophil elastase in plasma |  | day 5 | 
| concentration of IL-6 |  | day 0 | 
| concentration of IL-6 |  | day 1 | 
| concentration of IL-6 |  | day 3 | 
| concentration of IL-6 |  | day 5 | 
| concentration of IL-10 |  | day 0 | 
| concentration of IL-10 |  | day 1 | 
| concentration of IL-10 |  | day 3 | 
| concentration of IL-10 |  | day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Respiratory Distress Syndrome