Feasibility, Safety and Outcomes of Intensive Enteral Nutrition in Mechanical-ventilated Patients: a Multicenter, Parallel Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Incidence rate of hospital-acquired infections
研究概览
简要总结
Patients with mechanical ventilation are in risk of malnutrition, which could lead to worse outcome. According to guidelines released from authority organizations, enteral nutrition (EN) should be prior approach for critically ill patients. However, initiation and delivery of EN during the early period of ICU admission are frequently hampered, which results in underfeeding. The investigators speculate whether an intensive enteral nutrition strategy could reinforce the delivery of EN thereby improving outcomes. In this multi-center, prospective, randomized parallel clinical trial, the investigators aim to assess the feasibility, safety and outcomes of intensive enteral nutrition in mechanical-ventilated patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •predicted time of mechanical ventilation more than 48 hours
排除标准
- •no enteral nutrition pathway
- •refuse to informal consent
- •surgeon refuse the protocol
- •palliative care
结局指标
主要结局
Incidence rate of hospital-acquired infections
时间窗: 28 days after ICU admission
Hospital-acquired infections include ventilator-associated pneumonia, bloodstream infection, and urinary catheter-associated infection
次要结局
- rate of reaching 80% of energy target during 72 hours(first 72 hours after ICU admission)
- mortality of 28 days(28 days after ICU admission)
- ICU stay(from ICU admission to timepoint of patient's discharge or death, up to 12 months)
- free days of mechanical ventilation(during whole ICU stay, up to 12 months)
- EN-associated adverse events(during whole ICU stay, up to 12 months)
- rate of parenteral nutrition delivery(during whole ICU stay, up to 12 months)
研究者
Ming Zhong
associate professor
Shanghai Zhongshan Hospital