NCT02159456Unknown不适用
Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients: a Prospective, Randomized Controlled Trial
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
- 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.
- 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
- 否
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
Jinwoo Lee
Professor
Seoul National University Hospital
研究点 (2)
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