NCT00682500终止3 期
Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children
Pneuma Pharmaceuticals Incorporated32 个研究点 分布在 6 个国家目标入组 332 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 332
- 试验地点
- 32
- 主要终点
- Mortality Rate
研究概览
简要总结
This study will determine if administration of an suspension of calfactant, a lung surfactant, intratracheally in patients with Direct Acute Respiratory Distress Syndrome within 48 hours of requiring mechanical ventilation can decrease the mortality in patients with lethal disease and shorten the course of respiratory failure in patients with sub-lethal disease.
详细描述
Recruitment limited to direct adult respiratory distress syndrome patients who have been intubated <48 hours. Origin of ARDS must be infectious pneumonia, aspiration of stomach contents, near drowning, smoke inhalation without pulmonary burn, inhaled industrial gas.
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
- 12 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Respiratory failure due to diffuse infectious pneumonia, aspiration, near drowning, smoke inhalation or industrial gas
- •Less than 48 hours of mechanical ventilation
- •Informed consent
排除标准
- •Pre-existing lung disease
- •limited therapeutic goals (do not resuscitate, etc.)
- •failure of another vital organ
研究组 & 干预措施
1
Experimental
Calfactant treatment
干预措施: Calfactant (Drug)
2
Placebo Comparator
干预措施: Room Air (placebo) (Drug)
结局指标
主要结局
Mortality Rate
时间窗: 90 days
次要结局
- Duration of mechanical ventilation(90 days)
研究者
研究点 (32)
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