A Retrospective Investigator Initiated Trial Evaluating Protein Intake and CT Assessments of Muscle Mass of Critically Ill Patients in Relation to Outcome Parameters: the PROMUS-study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 主要终点
- All-cause mortality
研究概览
简要总结
The purpose of this study is to determine whether protein intake during the first days of intensive care admission, in relation to body composition at intensive care admission as assessed on computed tomography scans made during routine care, is are related to clinical outcome in critically ill patients.
详细描述
Optimal protein and energy intake have been shown to be relevant for reducing mortality in prospective observational studies in mechanically ventilated patients admitted to the intensive care unit. However, nutritional status (protein mass, muscle mass) of patients at admission and possible consequences for clinical outcome are largely unknown. Computerized tomography scans can be used to assess muscle mass as a proxy for body protein mass.
The investigators are especially interested in the effect of protein intake on clinical outcome in intensive care patients with different body protein mass at admission. This is relevant for appropriate formulation of clinical (protein) nutrition in this patient group. Therefore, the relationship between protein intake and patient outcome is evaluated in intensive care patients with low muscle and normal muscle area, using muscle area from computed tomography scans as a proxy of body protein mass.
Additionally, data from computed tomography scans regarding muscle quality and muscle- and fat quantity are used to evaluate the prognostic value of body composition at intensive care admission. Finally, abdominal computed tomography scans are compared with thoracic computed tomography scans.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Abdominal computed tomography scan made 1 day before up to 4 days after admission to the intensive care unit
- •Length of intensive care stay of at least 4 days
- •Mechanical ventilation during intensive care stay
排除标准
- •Computed tomography scan not eligible for analysis
- •Missing data
结局指标
主要结局
All-cause mortality
时间窗: From admission to the intensive care unit untill discharge from the hospital, an average of one month
次要结局
- Length of ventilation(The total duration of mechanical ventilation during intensive care unit stay, an average of 10 days)
- Percentage of patients discharged to home(After discharge from the hospital, on average after one month)
- Length of hospital stay (days)(The total duration of admission to the hospital, an average of one month)
- Length of intensive care unit stay(The total duration of admission to the intensive care unit, an average of two weeks)
研究者
Wilhelmus G.P.M. Looijaard, MD
PhD Candidate
Amsterdam UMC, location VUmc
