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临床试验/NCT02159456
NCT02159456Unknown不适用

Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients: a Prospective, Randomized Controlled Trial

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
70
试验地点
2
主要终点
Achievement rate of target nutritional goal

研究概览

简要总结

  1. Nutritional support during critical illness is important to improve the clinical outcome of patients. Recently, the apply of early enteral nutrition is recommend in critically ill patients on basis of data that enteral nutrition can be helpful to prevent the hospital-acquired infections.
  • However, in critically ill patients, the smooth progress of nutritional support is often hindered by gastrointestinal intolerance, underlying clinical condition, and temporal necessity of procedure or operation.
  • Continuous feeding method, compared with intermittent feeding, is expected to reduce the risk of gastrointestinal intolerance, and improve the nutritional support, but this hypothesis is not supported by appropriate evidences.
  1. We will elucidate to compare the efficacy and safety of the continuous feeding method in critically ill patients, compared with the intermittent feeding method.
  • Prospective, randomized controlled study
  • Primary outcome: the achievement rate of target nutritional goal within 7 days after the start of enteral nutrition
  • Secondary outcome: gastrointestinal tolerance, In-ICU/hospital mortality, frequency of hospital-acquired infection, ICU/hospital length-of-stay, duration of mechanical ventilation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • adult patient admitted in the intensive care unit
  • age 20 years old or more
  • The enteral nutritional support is expected to be available within 48 hours after ICU admission

排除标准

  • previous abdominal surgery within 1 month
  • gastrointestinal bleeding, bowel obstruction, refractory vomiting/diarrhea
  • hypersensitivity to prokinetics, history of seizure or phechromocytoma
  • enteral feeding via enterostomy or gastrostomy
  • difficulty to insert or maintain nasogastric tube
  • need for specialized feeding (ex: hemodialysis diet, chronic renal failure diet, diabetes diet)
  • pregnancy

结局指标

主要结局

Achievement rate of target nutritional goal

时间窗: Within 7 days after the start of enteral feeding

次要结局

  • ICU/hospital mortality(During hospital admission)
  • Gastrointestinal tolerance(Within 7 days after start of enteral feeding)
  • Frequency of hospital-aquired infection(During hospital admission)
  • ICU/hospital length-of-stay(During hospital admission)
  • Duration of mechanical ventilation(During hospital admission)

研究者

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

Jinwoo Lee

Professor

Seoul National University Hospital

研究点 (2)

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