Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients Guided by Indirect Calorimetry, a Prospective, Blinded, Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- All cause mortality, ICU mortality, Hospital mortality.
研究概览
简要总结
Underfeeding in the critically ill patient is a common observable fact throughout intensive care units. Patients who develop caloric deficit during their stay in the ICU have been shown in previous reports to be associated with increased complications such as increased rate of infections, and nosocomial blood stream infections. Yet, other studies have shown that patients with moderate caloric deficit may be associated with better outcome than patients who receive higher levels of caloric intake.
详细描述
Therefore, the aim of our study is to establish the exact amount of calories to be delivered by indirect calorimetry individually for each patient. Thereafter, each patient will be randomized to the trophic group (hypocaloric feeding), or to the full energy delivery group.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Anticipated Mechanical ventilation for at least 72 hrs.
- •Need for enteral feeding
- •men and woman aged 18 or older.
排除标准
- •Abdominal surgery with inability to feed enterally.
- •FiO2 greater than 80%
- •Bronchopleural fistula
- •Hemodynamic instability in spite the use of vassopressors.
结局指标
主要结局
All cause mortality, ICU mortality, Hospital mortality.
时间窗: 1 year
All cause mortality, ICU mortality, Hospital mortality.
次要结局
- ICU and Hospital LOS, Length of mechanical ventilation, rate of infections,(1 year)
研究者
Soroksky Arie
M.D.
Wolfson Medical Center