EUCTR2007-005901-23-IT进行中（未招募）不适用
Prospective,Double-Blind Randomized Clinical Trial on the Effects of Early Administration of Prolonged Methylprednisolone Therapy in early Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) - ND
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 个研究点目标入组 400 人开始时间: 2007年12月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age. Patients age 18 years or older admitted to the intensive care unit.
- •2. ALI/ARDS criteria. The diagnosis of ALI/ARDS requires all of the following
- •Respiratory failure requiring mechanical ventilation ? via endotracheal intubation
- •or noninvasive positive pressure ventilation
- •Acute onset of bilateral pulmonary densities on chest radiograph in the contest of
- •appropriate predisposing injury or illness with no evidence of left ventricular failure,
- •Static pulmonary compliance < 50 cm H2O
- •Ratio of partial pressure of arterial oxygen to partial pressure of alveolar oxygen
- •(PaO2:FiO2 ) equal or less than 300 (criteria for ALI) or 200 (criteria for ARDS)with FiO2 1.0.
- •3. Severe ARDS. PaO2:FiO2 equal or less than 200 after 30 minutes of standardized ventilatory management on PEEP of 10 cm H2O with FiO2 1.0.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Failure to obtain written informed consent;trauma-induced ARDS;major gastrointestinal bleeding requiring transfusion of 5 units or more of packed red blood cells (PRBC) within 3 months current hospitalization;condition requiring > 0.5mg/Kg/day of prednisone equivalent (i.e., acute asthma or chronic obstructive pulmonary disease [COPD]);patients enrolled in another experimental (interventional) protocol within the past 30 days;pregnancy confirmed by urine or serum test; weight is > 200% of ideal body weight; immunosuppression including HIV+ status;severe chronic liver disease (Child-Pugh Class C score > 10 points)
研究者
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