NCT01814956终止4 期
Prospective, Randomized, Controlled, Double-blind, Parallel-group, Mono-center, 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
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- change in blood oxygenation (PaO2/FiO2ratio)
研究概览
简要总结
Aim is to investigate the influence of an early supply of parenteral nutrition including a fish oil containing lipid emulsion on the course of acute lung injury in the intensive care unit. In comparison, a standard parenteral nutrition with a soybean oil based emulsion will be used. Data obtained in this trial may provide evidence for a beneficial effect of fish oil derived omega-3 fatty acids in parenteral nutrition regarding their influence on acute lung injury.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
i.v. lipid emulsion for parenteral nutrition
干预措施: Lipoplus 20% (Drug)
2
Active Comparator
i.v. lipid emulsion for parenteral nutrition
干预措施: Lipofundin N 20% (Drug)
结局指标
主要结局
change in blood oxygenation (PaO2/FiO2ratio)
时间窗: change day 1 to day 6
次要结局
- Triglycerides(day 1 to day 16)
- Sequential Organ Failure Assessment(day 1 to day 28)
研究者
研究点 (1)
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