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临床试验/NCT02976155
NCT02976155已完成不适用

The Effect of a Standard Enteral Nutrition Protocol on Critically Ill Patients: a Multiple-center, Prospective, Before-after Study

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 439 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
439
试验地点
1
主要终点
The proportion of patients receiving enteral nutrition in patients receiving any type of nutrition

研究概览

简要总结

The goal of this study is to evaluate whether a standard enteral nutrition protocol can improve the efficiency in achieving nutritional goals and improve prognosis in critically ill patients.

详细描述

As investigators all know, the nutrition status in critically ill patients is associated with the prognosis of these patients. And it has been confirmed that early enteral nutrition results in better outcome. However,some epidemiological investigation reported that in most intensive care unit, the phenomenon of delayed feeding or under feeding are not uncommon. In 2007, a study reported that the percentage of early enteral nutrition within 48h is 64%, based on mechanical ventilated patients in 208 intensive care unit nationally. Other study indicated that the calorie supported by the enteral nutrition only constitute 50% of the target calorie. Several studies have showed that the application of a standard enteral nutrition protocol could result in an improvement in the delivery of enteral feedings to patients. However, there is no such study in China.The goal of this study is to evaluate whether a standard enteral nutrition protocol can improve the efficiency in achieving nutritional goals and improve prognosis in critically ill patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Critically ill patients who is expected the length of ICU stay for more than 3 days

排除标准

  • Patients who can obtain enough calorie through independent oral feeding. Patients aged less than 18 years. Patients who are pregnant or breastfeeding. Patients who are burned. Patients with malignant tumor terminal stages of diseases

结局指标

主要结局

The proportion of patients receiving enteral nutrition in patients receiving any type of nutrition

时间窗: 7 days after ICU admission

The proportion of patients receiving parenteral nutrition in patients receiving any type of nutrition

时间窗: 7 days after ICU admission

The proportion of patients receiving Enteral plus supplement parenteral in patients receiving any type of nutrition

时间窗: 7 days after ICU admission

The time from hospital admission to the begain Enteral nutrition.

时间窗: 7 days after ICU admission

The time from hospital admission to achieve the target calorie.

时间窗: 7 days after ICU admission

次要结局

  • ICU mortality.(From date of the ICU admission until discharge form ICU,assessed up to 12 months)
  • Hospital mortality.(From date of the ICU admission until discharge form hospital,assessed up to 12 months)
  • ICU length of stay(From date of the ICU admission until discharge form ICU,assessed up to 12 months)
  • Duration of mechanical ventilation.(From date of the initiation of mechanical ventilation until weaning,assessed up to 12 months)
  • ICU fee.(From date of the ICU admission until discharge form ICU,assessed up to 12 months)
  • The incidence of complications(Diarrhea , abdominal distension, nausea and vomiting.)(From date of the ICU admission until discharge form ICU,assessed up to 12 months)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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