NCT00074906已完成3 期
Venticute in Patients With Pneumonia or Aspiration of Gastric Contents Leading to Intubation, Ventilation, and Severe Oxygenation Impairment: A Randomized, Multinational, Multicenter, Parallel Group, Double Blind, Control Group Study
Takeda93 个研究点 分布在 10 个国家目标入组 1,200 人开始时间: 2003年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 试验地点
- 93
- 主要终点
- Survival on day 28
研究概览
简要总结
Study to demonstrate that administration of Venticute increases survival of patients with pneumonia or aspiration of gastric contents leading to intubation, mechanical ventilation, and severe oxygenation impairment.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Main inclusion criteria:
- •Patient has been intubated due to one of the following primary pulmonary insults: aspiration of gastric contents or pneumonia
排除标准
- •Principal source of infection or sepsis is outside the lung
- •Severe pre-existing lung disease
- •Cancer metastatic to the lung or any end stage malignancy
- •History of lung, liver, pancreas, small bowel, or bone marrow/stem cell transplantation
- •Patient is morbidly obese
- •Patient has a diagnosis of acute necrotizing pancreatitis
- •Additional criteria may apply and examination by an investigator is required to determine eligibility.
结局指标
主要结局
Survival on day 28
时间窗: 28 days
次要结局
- How long the lung and the patient (overall) are recovering(28 days)
研究者
研究点 (93)
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