NCT00440453已完成4 期
Feeding the Patient at Nutritional Risk: Does the Clinical Outcome Improve?
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Length of stay
研究概览
简要总结
The aim of the present study is to take stronger action in solving the problems of malnutrition in the hospital setting and in the first two months after patient's discharge. The main objective is to evaluate the clinical benefit (eg. QoL, body composition and body function) of nutritional intervention (nutritional therapy) in a sample of patients at nutritional risk according to the NRS 2002.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •all patients coming on station
排除标准
- •patients with a screening total score <3 according to the NRS-2002 system
- •less than 18 years of age, expected hospital stay less than 4 days
- •expected survival less than 1 month
- •pregnant or lactating women
- •patients with psychiatric disorders
- •patients with cardiac failure as defined by the Goldmann classification class >II (recent rest pain, unstable angina pectoris)
- •patients with respiratory failure (Peak Flow Rate: PEFR <50%)
- •patients with hepatic dysfunction (Child >A)
- •patients suffering from an intestinal obstruction or ileus
- •patients with renal failure (creatinine >250 μmol/l) or receiving haemodialysis
- •patients that are already receiving, or are planned to receive parenteral nutrition
- •patients unable to understand the German language
结局指标
主要结局
Length of stay
时间窗: after stay
次要结局
- Quality of life(2 months after stay)
- Changes in body weight (measured day 1-2, 8, 28 and 56) and body composition (BMI, MAC, TSF) (measured day 1-2 and 8)(during stay)
- Changes in muscle function (handgrip dynamometry) (measured day 1-2 and 8)(during stay)
- Rate of accurately defined complications (infectious and non-infectious) (Table 2). Infectious are defined according to the US Centre of Disease Control [115].(during stay)
- Rate of accurately defined post-discharge complications (infectious and non-infectious) (Table 2)(after stay)
- Rate of re-hospitalization (within 8 weeks after randomisation)(after stay)
- Rate of mortality(during and after stay)
研究者
研究点 (2)
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