Effect of Early Treatment With Sivelestat Sodium on Lung Function and Inflammatory Response of ARDS Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- The serum levels of IL-6
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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）;
排除标准
- •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.
研究组 & 干预措施
Sivelestat Sodium group
Patients treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS.
干预措施: Sivelestat sodium (Drug)
结局指标
主要结局
The serum levels of IL-6
时间窗: change from admission to 7 days after enrollment
Murray lung injury score
时间窗: 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
次要结局
- liver function(change from admission to 7 days after enrollment)
- 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(change from admission to 7 days after enrollment)
- coagulation function(change from admission to 7 days after enrollment)
- myocardial injury indexes(change from admission to 7 days after enrollment)
- infection and immunity(change from admission to 7 days after enrollment)
- Incidence of new organ insufficiency/failure after enrollment(up to 2 years)
- respiratory function(change from admission to 7 days after enrollment)
- 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)