NCT00772096已完成4 期
Septic Encephalopathy and Late Cognitive Dysfunction in Patients With Sepsis - the Role of Inflammation
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年10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
- 50
- 试验地点
- 1
研究概览
简要总结
Delirium and long-term cognitive dysfunction are important problems in intensive care patients. Patients with sepsis are at a high risk of developing delirium (septic encephalopathy), which may be an important risk factor for the development of long-term cognitive dysfunction.
Working hypotheses: 1. Septic encephalopathy and cognitive dysfunction are caused by an unspecific reaction of the brain to an intense inflammatory stimulus. 2. It is possible to therapeutically influence the inflammatory response and its effects on the brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, 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
- •Admitted to an intensive care unit for treatment of sepsis, severe sepsis or septic shock
- •Age 18 or older
排除标准
- •Primary infection of the CNS
- •History of cerebrovascular disease
- •History of any neoplasia involving the CNS
- •History of long-term psychiatric medication
- •History of allergy to fish- or egg-protein
- •Severe coagulation abnormalities
- •Clinical signs of altered coagulation, active bleeding
- •Pregnancy
研究组 & 干预措施
Verum
Experimental
干预措施: n-3 fatty acids (Drug)
研究者
研究点 (1)
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