Effect of Early Treatment With Sivelestat Sodium in ARDS Patients

Study Overview
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Brief Summary
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This study is a multicenter, prospective, observational cohort study. The subjects were patients who developed ARDS within the preceding 72h. They were divided into 2 groups based on the use of sivelestat sodium which was determined by the physician in charge based on the condition of the patients: sivelestat sodium group and conventional treatment group. 560 patients were planned to be enrolled, with 280 patients in each group. In the sivelestat sodium group, patients were treated with sivelestat sodium within 72h of the diagnosis of ARDS. After 5 days of sivelestat treatment, sivelestat treatment should be stopped if the oxygenation index is greater than 300mmHg for at least 3 consecutive times; otherwise, sivelestat treatment should be continued until the oxygenation index is greater than 300mmHg for at least 3 consecutive times; if sivelestat treatment is continued until the 14th day, the drug should be stopped regardless of the oxygenation situation. Baseline data and Murray lung injury score, inflammatory markers, routine test results, duration of ECMO use/length of hospital stay/length of ICU stay were recorded at 1, 3,5, and 7 days after patients were enrolled, and patients were followed up on the 28th and 90th days.

Official Title
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Effect of Early Treatment With Sivelestat Sodium on Lung Function and Inflammatory Response of ARDS Patients

Conditions
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ARDS, Inflammatory Response

Intervention / Treatment
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* Drug: Sivelestat sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntarily signed informed consent; ≥18 years old; Patients developed ARDS in the preceding 72h; The total scores of the Murray lung injury scores were greater than 6 （When lung compliance was not measured, the total scores of the other three scores were greater than 4）; Exclusion Criteria: Pregnancy or lactation; ARDS was diagnosed for more than 72 hours; Sivelestat sodium was used for treatment prior to enrollment; Patients with more than 3 extra-pulmonary organ injuries/failure; Severe chronic liver disease (Child-pugh grade C); Previous history of allergy to sivelestat sodium or any of its ingredients or preservatives; Patients whose primary disease cannot be effectively controlled; Patients judged by the investigator to be unsuitable for participation in this study.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sivelestat Sodium group<br>Patients treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS. | Drug: Sivelestat sodium<br>* Patients were treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS.<br>|
| Conventional treatment group<br>Patients not treated with Sivelestat Sodium/Normal Saline after the diagnosis of ARDS | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Murray lung injury score | The Lung Injury Score can be used to assess the adult patient for the extent of acute pulmonary damage. It can be used both at the onset of a lung disorder and during the course of the illness to monitor changing lung involvement. Parameters chest X-ray evaluated for alveolar consolidation ratio of the partial pressure of oxygen in arterial blood to the inspiratory fraction of oxygen PEEP level if ventilated respiratory compliance if known | change from admission to 7 days after enrollment | 
| The serum levels of IL-6 |  | change from admission to 7 days after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capillary leakage index | Ultrasound lung water score, capillary leakage index | change from admission to 7 days after enrollment | 
| Serum levels of leukocytes |  | change from admission to 7 days after enrollment | 
| Serum electrolyte level |  | change from admission to 7 days after enrollment | 
| renal function | The serum levels of creatinine | change from admission to 7 days after enrollment | 
| liver function | The serum levels of ALTand AST | change from admission to 7 days after enrollment | 
| myocardial injury indexes | The serum levels of cTnT, CK-MB | change from admission to 7 days after enrollment | 
| respiratory function | oxygenation index | change from admission to 7 days after enrollment | 
| infection and immunity | The serum levels of CRP | change from admission to 7 days after enrollment | 
| infection and immunity | The serum levels of PCT | change from admission to 7 days after enrollment | 
| infection and immunity | The serum levels of IL-10 and IL-1β | change from admission to 7 days after enrollment | 
| infection and immunity | The serum levels of TNF-α | change from admission to 7 days after enrollment | 
| coagulation function | The serum levels of APTT, PT, TT | change from admission to 7 days after enrollment | 
| coagulation function | The serum levels of INR | change from admission to 7 days after enrollment | 
| coagulation function | The serum levels of Fbg | change from admission to 7 days after enrollment | 
| Incidence of new organ insufficiency/failure after enrollment |  | up to 2 years | 
| length of ventilation/length of hospital stay/length of ICU stay |  | up to 2 years | 
| Mortality rate of in-hospital /28d/90d |  | 90 days after admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sivelestat, ARDS, Inflammatory Response, lung function