Optimization of Nutritional Therapy by Variation of Methods to Determine Energy Needs in Mechanically Ventilated, Critically Ill Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Phase angle (PhA)
研究概览
简要总结
The aim of this study is to investigate whether an individualized determination of energy requirements using indirect calorimetry instead of a formula-based approach leads to an optimized nutritional support and as a consequence to an optimized nutritional status of the critically ill, mechanically ventilated patients measured by the phase angle.
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
- None
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
- •age over 18 years
- •mechanical ventilation
- •an hospital stay of at least three days at the intensive care unit of the University Hospital of Tübingen
- •possibility to perform indirect calorimetry measurements (FiO2 ≤70, PCO2 ≤ 0,5)
- •possibility to perform Bioelectrical Impedance Analysis (BIA)
- •underlying indication for enteral or/and parenteral nutritional support
- •written informed consent from the patient or a legal authorized person
排除标准
- •cardiac pacemaker
研究组 & 干预措施
Indirect Calorimetry
The energy need is being determined by using indirect calorimetry and if necessary, optimized by parenteral, enteral and additive parenteral nutrition.
干预措施: Indirect Calorimetry (Other)
Standard Care
This group receives nutrition supply according to the hospital routine ("standard care")
结局指标
主要结局
Phase angle (PhA)
时间窗: PhA was measured between one and 90 days (during ICU stay)
The primary endpoint is the change of the phase angle during the stay in the intensive care unit (ICU). A mean difference of 5% is considered as relevant.
次要结局
- Nitrogen Balance(Nitrogen Balance was measured between one and 90 days (during ICU stay))
- Extracellular to body cell mass ratio (ECM/BCM - Ratio)(ECM/BCM-Ratio was measured between one and 90 days (during ICU stay))
- Length of hospital stay in days(Length of hospital stay was measured between one and 180 days)
- Length of stay in intensive care unit (ICU) in days(Length of ICU stay was measured between one and 90 days)