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| Name | Class |
|---|---|
| Shenzhen Hospital of Southern Medical University | OTHER |
| Guangdong No.2 Provincial People's Hospital | OTHER |
| Foshan Hospital of Traditional Chinese Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sivelestat Sodium group | Patients treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS. |
| |
| Conventional treatment group | Patients not treated with Sivelestat Sodium/Normal Saline after the diagnosis of ARDS |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sivelestat sodium | Drug | Patients were treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS. |
|
| 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
| change from admission to 7 days after enrollment |
| The serum levels of IL-6 | change from admission to 7 days after enrollment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients developed ARDS in the preceding 72h
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern medical university Nanfang hospital | Guangzhou | 510515 | China |
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blood
| 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 |