NCT00560157已完成4 期
Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients
Société des Produits Nestlé (SPN)4 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2002年12月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Variation of Glutamine after 90 min of enteral product administration
研究概览
简要总结
Comparison of metabolic and nutritional effects of an enteral immune enhancing diet with those of a standard polymeric one, in ICU patients
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
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* requiring the administration of an exclusive tube feeding nutrition during 7 days and beginning at the latest in the three days following the aggression
- •* ICU patients hospitalized for:
- •* neurologic affections
- •* pneumopathy
- •* major abdominal surgery or serious acute pancreatitis
- •* written informed consent
排除标准
- •pregnancy or breast feeding
- •immunosuppressive therapy
- •radiotherapy or chemotherapy in the last six month
- •uncontrolled septic choc
- •auto-immune disease
- •hepatic,renal or digestive insufficiency
- •hyperlipidemia
- •diabetes mellitus type 1
- •digestive malabsorption
- •life threatening situation
- •treatments with growing hormone, glutamine or its metabolites or precursors such as ornithine alpha keto glutarate
结局指标
主要结局
Variation of Glutamine after 90 min of enteral product administration
时间窗: J5
次要结局
- Nutritional parameters, immunologic parameters, functionality renal, Biological marker of oxidative stress(J1, J5, J8)
- Tolerance(Daily until J8)
研究者
研究点 (4)
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