NCT00219375已完成4 期
Efficacy and Safety of Sivelestat Sodium Hydrate in Acute Lung Injury Associated With Systemic Inflammatory Response Syndrome, Compared With the Conventional Treatment in Japan
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 649
- 试验地点
- 9
- 主要终点
- Ventilator free days (VFD)
研究概览
简要总结
The purpose of this study is to confirm the efficacy and safety of sivelestat in patients with acute lung injury associated with systemic inflammatory response syndrome. The results will be compared to the study with conventional treatment without sivelestat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with systemic inflammatory response syndrome (SIRS)
- •Patients with acute lung injury (ALI) assessed using the criteria specified by the American-European Consensus Conference
- •Within 72 hours of onset of lung injury
- •Other inclusion criteria as specified in the protocol
排除标准
- •Already administrated Sivelestat before enrollment in the study
- •Neuromuscular disease that impairs spontaneous ventilation
- •Severe central nervous system disease
- •Bone marrow transplant
- •Lung transplant
- •Severe chronic liver disease
- •Neutropenia (neutrophil count: below 1000/mm3)
- •Other exclusion criteria as specified in the protocol
研究组 & 干预措施
E1
Experimental
This arm is conducted as a separate study (12-601-0001)
干预措施: Sivelestat sodium hydrate (Drug)
E2
Experimental
This arm is conducted as a separate study (12-603-0001).
干预措施: Sivelestat sodium hydrate (Drug)
结局指标
主要结局
Ventilator free days (VFD)
时间窗: 28 days
次要结局
- 28-day period survival rate, weaning rate from mechanical ventilation, intensive care unit (ICU) discharge rate, lung injury scores(28 days)
研究者
研究点 (9)
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