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临床试验/NCT01922570
NCT01922570已完成不适用

Economic Investigation of Diarrhoea During Nutritional Support in Intensive Care Unit Patients

University Hospital, Geneva2 个研究点 分布在 1 个国家目标入组 305 人开始时间: 2012年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
305
试验地点
2
主要终点
Cost of diarrhea

研究概览

简要总结

Enteral nutrition (EN) is the first choice route for nutritional support in ICU patients with a functioning digestive tract. Nevertheless, EN alone is often associated with digestive intolerance, including diarrhoea. In case of diarrhoea, EN is often reduced or discontinued, resulting in insufficient energy and protein intakes and increase complications rate in ICU patients. Diarrhoea is more frequent in ICU patients receiving EN that in those without EN or on Parenteral nutrition (PN). This difference is likely to be related to the level of EN administration needed to optimize the coverage of nutritional needs at a time when the gut has reduced absorptive capacity. Diarrhoea is suspected to have a negative economic impact on global cost, because the management of patients with diarrhoea is time-consuming for the nurses and all medical staff, it requires investigations (water and electrolytes balances, microbiology investigations, etc.) and treatments (anti-diarrhoeal drugs, antibiotics, etc). However, the economic impact of diarrhoea related to EN or the combination of EN and PN has never been evaluated in the ICU setting.

详细描述

Rationale: Enteral nutrition (EN) is the first choice route for nutritional support in ICU patients with a functioning digestive tract (1). Nevertheless, EN alone is often associated with digestive intolerance, including diarrhoea (2,3). In case of diarrhoea, EN is often reduced or discontinued, resulting in insufficient energy and protein intakes (4) and increase complications rate in ICU patients (5-7). Diarrhoea is more frequent in ICU patients receiving EN that in those without EN or on PN. This difference is likely to be related to the level of EN administration needed to optimize the coverage of nutritional needs at a time when the gut has reduced absorptive capacity. Diarrhoea is suspected to have a negative economic impact on global cost, because the management of patients with diarrhoea is time-consuming for the nurses and all medical staff, it requires investigations (water and electrolytes balances, microbiology investigations, etc.) and treatments (anti-diarrhoeal drugs, antibiotics, etc). However, the economic impact of diarrhoea related to EN or the combination of EN and PN has never been evaluated in the ICU setting.

Hypothesis: We made the hypothesis that the extra cost related to the combination of EN and PN prescription is compensated by the decrease in cost secondary to a reduced prevalence of EN-related diarrhoea, which means that the combination of EN and PN is cost-efficient strategy for optimal feeding in ICU patients.

It is known that:

  • diarrhoea is more frequent in ICU patients with EN than in those without EN,
  • the higher the EN delivery rate, the higher the risk of diarrhoea,
  • the combination of EN and PN decreases the need for high EN delivery rate to fully cover the patients' nutritional needs.

It is likely that:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with an indication to receive enteral nutrition

排除标准

  • patients with a contraindication to receive enteral nutrition

研究组 & 干预措施

Dietary supplements:parenteral nutrition

Experimental

supplemental parenteral nutrition and enteral nutrition in case of failure (intake below 60% of energy needs) of enteral nutrition by day 3 after admission in the ICU or enteral nutrition only.

干预措施: nutrition (Dietary Supplement)

结局指标

主要结局

Cost of diarrhea

时间窗: day 28

Swiss francs: All costs (manpower, investigations, treatments) related to diarrhea during the ICU stay up to 28 days are reported as Swiss francs

次要结局

  • Use of enteral nutrition(day 28)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Claude Pichard

Head, Clinical Nutrition

University Hospital, Geneva

研究点 (2)

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