NCT00634075已完成4 期
Clinical Assessment of Fish Oil-based Lipid Emulsion Infusions in Critical Patients With Severe Sepsis
Li Shin Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- All cause mortality
研究概览
简要总结
The purpose of this study is to determine whether a fish oil-based lipid emulsion, enriched with ω-3 fatty acids, reduce proinflammatory cytokines and mortality rate in critically ill patients with severe sepsis.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to Li Shin Hospital's ICU with a main diagnosis of severe sepsis.
排除标准
- •Age of ﹤15 years
- •Pregnancy
- •Patients treated with immunosuppressive drugs or the equivalent of hydrocortisone more than 300 mg daily
- •Plasma triglyceride concentration of more than 400 mg/dl
- •Infection with human immunodeficiency virus
- •Anticipated rapid fatality from irreversible underlying disease or malignancy
- •Severe hemorrhagic disorders
- •Acute myocardial infarction
- •Recent stroke (within 3 month)
- •Suspected or proven pulmonary embolism
- •Cirrhotic liver and/or acute hepatitis ( elevation of serum GOT or GPT > 5 times of normal upper limit)
- •Chronic renal failure (Cr >3.5 mg/dl upon admission) or end stage of renal diseases
- •Allergic reactions against fish or egg proteins.
研究组 & 干预措施
1
Experimental
干预措施: omega-3-fatty acids (Omegaven) (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
All cause mortality
时间窗: mortality rate on days 7 and 28.
次要结局
- Lengths of ICU and hospital stay. Duration of mechanic ventilator requirement. Serial changing APACHE II and SOFA score. Changing of TNF-α, IL- 1β, IL-6, IL-8, and IL-10 levels. Incidence of hospital-acquired infection.(Days 0, 1, 3, 5, 7, 14 and 28.)
研究者
研究点 (1)
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