Efficacy of Sivelestat Sodium in the Treatment of ARDS With SIRS, a Multicenter Double-blind Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- oxygenation improvement rate
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Sivelestat Sodium
干预措施: Sivelestat sodium (Drug)
Saline
干预措施: Saline (Drug)
结局指标
主要结局
oxygenation improvement rate
时间窗: day 3
ventilator free days
时间窗: day 28
次要结局
- concentration of IL-10(day 5)
- 28 days mortality(day 28)
- oxygenation improvement rate(day 5)
- incidence of severe adverse effect(day 28)
- concentration of IL-6(day 5)
- Incidence of acquired infections(day 28)
- activity of neutrophil elastase in plasma(day 5)
- Invasive mechanical ventilation rate(day 28)
- length of stay in ICU(day 28)
- length of stay in hospital(day 28)
- ICU mortality(day 28)
- concentration of IL-6(day 1)
- concentration of IL-6(day 3)
- activity of neutrophil elastase in plasma(day 1)
- activity of neutrophil elastase in plasma(day 3)
- concentration of IL-6(day 0)
- 28-day ventilator-free days(day 28)
- oxygenation improvement rate(day 1)
- activity of neutrophil elastase in plasma(day0)
- concentration of IL-10(day 0)
- concentration of IL-10(day 1)
- concentration of IL-10(day 3)
研究者
He Hongli
Principal Investigator
Sichuan Provincial People's Hospital