NCT03111212已完成3 期
Therapeutic Iloprost for the Treatment of Acute Respiratory Distress Syndrome (ARDS) (the ThIlo-Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Oxygenation Index on Day 5 of Prostacyclin Treatment measured as PaO2/FiO2
研究概览
简要总结
The patients will be randomized into one of two groups. Both groups will receive standard care as is state of the art. The intervention group will receive Iloprost nebulized as inhalative therapy.
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
- 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
- •Horowitz index <300
- •Bilateral opacities on frontal chest radiograph
- •requirement of positive pressure ventilation
- •no clinical evidence of left atrial hypertension
- •enrollment within 48h of onset of ARDS
- •mechanical ventilation <7 days
排除标准
- •age <18 years
- •mechanical ventilation >7 days
- •patient, surrogate or physician not committed to full intensive care support
- •pregnancy
研究组 & 干预措施
Iloprost
Active Comparator
干预措施: Iloprost (Drug)
control
Placebo Comparator
干预措施: control (Drug)
结局指标
主要结局
Oxygenation Index on Day 5 of Prostacyclin Treatment measured as PaO2/FiO2
时间窗: Day 6 of Study
partial pressure of oxygen in blood (PaO2), in millimeters of mercury divided by the fraction of oxygen in the inhaled air (FiO2)
次要结局
- Number of Patients with Pulmonary Embolism(until ICU discharge, estimated average = 14 days)
- Overall survival in 90-day follow-up period(on day 90 after randomization and study entry)
- Sequential Organ Failure Assessment Score (SOFA Score)(until ICU discharge, estimated average = 14 days)
- Number of Patients with the Occurence of Barotrauma(until ICU discharge, estimated average = 14 days)
- Duration of Mechanical Ventilation(until ICU discharge, estimated average = 14 days)
- Number of Patients with Pulmonary Hemorrhage(until ICU discharge, estimated average = 14 days)
- Number of Patients with Gastrointestinal Hemorrhage(until ICU discharge, estimated average = 14 days)
- Number of Patients with Delirium(until ICU discharge, estimated average = 14 days)
- Number of Patients with ICU Acquired Weakness(until ICU discharge, estimated average = 14 days)
- Discharge Location(until ICU discharge, estimated average = 14 days)
- Barthel Index (BI)(at 6 months after study inclusion)
研究者
研究点 (1)
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