EUCTR2011-003397-82-DE进行中（未招募）不适用
Prospective, randomized, controlled, double-blind, parallel-group, mono-centre, explorative Phase IV trial on the efficacy and safety of a fish oil containing lipid emulsion versus a standard soybean oil-based lipid emulsion in patients with Acute Lung Injury
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Acute Lung Injury (ALI) as a result of proven pneumonia (x-ray) or wittnessed aspiration,
- •PaO2/FiO2 = 300 or less,
- •less than 72 hours since intubation or non-invasive ventilatory support by mask at screening,
- •expected need for parenteral nutrition for at least 5 days
- •full care on ICU,
- •male or female,
- •18 years of age or older
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Cardiogenic pulmonary oedema,
- •Previous or ongoing need for corticosteroid therapy with more than 0.1mg/kg /day prednisolon-equivalent or other immune-suppressive treatment,
- •Previous (< 1 year) or active treatment for solid or haematologic malignancy,
- •Serum Triglycerides > 300 mg/dl at screening,
- •Alterations of coagulation (thrombocytes < 100 Giga/l), aPTT > 60 sec, INR equal or > than 2.5 without therapeutic intevention,
- •Parenteral nutrition with SMOF or Omegaven,
- •Enteral nutrition with Pulmocare, Oxepa or Impact (any variety),
- •Autoimmune disease or HIV,
- •Known or suspected drug abuse,
- •Hypersensitivity to egg, fish, or soya-bean protein or to any of the active substances or excipients,
- •Severe renal failure without access to haemofiltration or dialysis,
- •Severe liver failure with bilirubin > 2.5 mg/dL,
- •Acute phase of myocardial infarction or stroke before timely scheduled interventional treatment and stabilization,
- •Acute thromboembolic disease until stabilization,
- •Lipid embolism
研究者
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