siv-ARDS: Effect of Early Treatment With Sivelestat Sodium in ARDS Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sivelestat Sodium group Patients treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS. |
Drug: Sivelestat sodium
Patients were 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 |
Outcome Measures
Primary Outcome Measures
- Murray lung injury score [change from admission to 7 days after enrollment]
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
- The serum levels of IL-6 [change from admission to 7 days after enrollment]
Secondary Outcome Measures
- Capillary leakage index [change from admission to 7 days after enrollment]
Ultrasound lung water score, capillary leakage index
- 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 [change from admission to 7 days after enrollment]
The serum levels of creatinine
- liver function [change from admission to 7 days after enrollment]
The serum levels of ALTand AST
- myocardial injury indexes [change from admission to 7 days after enrollment]
The serum levels of cTnT, CK-MB
- respiratory function [change from admission to 7 days after enrollment]
oxygenation index
- infection and immunity [change from admission to 7 days after enrollment]
The serum levels of CRP
- infection and immunity [change from admission to 7 days after enrollment]
The serum levels of PCT
- infection and immunity [change from admission to 7 days after enrollment]
The serum levels of IL-10 and IL-1β
- infection and immunity [change from admission to 7 days after enrollment]
The serum levels of TNF-α
- coagulation function [change from admission to 7 days after enrollment]
The serum levels of APTT, PT, TT
- coagulation function [change from admission to 7 days after enrollment]
The serum levels of INR
- coagulation function [change from admission to 7 days after enrollment]
The serum levels of Fbg
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Voluntarily signed informed consent;
-
≥18 years old;
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Patients developed ARDS in the preceding 72h;
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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:
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Pregnancy or lactation;
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ARDS was diagnosed for more than 72 hours;
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Sivelestat sodium was used for treatment prior to enrollment;
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Patients with more than 3 extra-pulmonary organ injuries/failure;
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Severe chronic liver disease (Child-pugh grade C);
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Previous history of allergy to sivelestat sodium or any of its ingredients or preservatives;
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Patients whose primary disease cannot be effectively controlled;
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Patients judged by the investigator to be unsuitable for participation in this study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Nanfang Hospital of Southern Medical University
- Shenzhen Hospital of Southern Medical University
- Guangdong No.2 Provincial People's Hospital
- Foshan Hospital of Traditional Chinese Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NFEC-2021-187