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临床试验/NCT03216993
NCT03216993Unknown不适用

The Shanghai Protocol for Early Enteral Nutrition in Mechanical Ventilated Patients

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
energy target fulfilling rate

研究概览

简要总结

compare different enteral nutrition strategy in patients with mechanical ventilation

详细描述

There has been many evidence that deficiency in energy and protein take-in are associated with poor outcome in critical patients. To reach an adequate amount of energy and protein is critical in patients with respiratory failure and with mechanical ventilation, as it prevents muscle dystrophy and thus prevents ICU acquired weakness, leading to a better outcome in the end. Enteral Nutrition is preferred as it prevents gut dysfunction in respiratory failure patients, and may prevent further infection. But there are many challenge in implement a good enteral nutrition therapy, and energy or protein deficiency is common in patient with respiratory failure. There have been many protocols aiming at reaching enough enteral nutrition for ICU patients, most of which are based on a background of western and developed countries. The investigators developped a enteral nutrition protocol based on an unique cultural background of eastern developing country, trying to help the ICU patients reaching nutrition target, so that the patients may have better outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ICU patients
  • Receiving mechanical ventilation (MV) both Non-invasive ventilation and invasive ventilation
  • Expecting MV more than 72 hours

排除标准

  • Pregnancy
  • ICU stay < 72hr

研究组 & 干预措施

Standard care

Other

Standard care: patients receive enteral nutrition in accordance with the usual practice in the participating units

干预措施: Standard care (Other)

Protocol care

Experimental

Protocol care: patient receive enteral nutrition in accordance with enteral nutrition protocol studied

干预措施: Protocol care (Other)

结局指标

主要结局

energy target fulfilling rate

时间窗: 7 days from enrollment

the proportion of patients in both arms meeting the targeted energy in-take

protein target fulfilling rate

时间窗: 7 days from enrollment

the proportion of patients in both arms meeting the targeted protein in-take

次要结局

  • mortality(28 days from enrollment)

研究者

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

Erzhen Chen

Professor

Ruijin Hospital

研究点 (1)

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