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临床试验/NCT02817646
NCT02817646已完成不适用

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

Amsterdam UMC, location VUmc0 个研究点目标入组 800 人开始时间: 2012年2月最近更新:
适应症

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

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

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wilhelmus G.P.M. Looijaard, MD

PhD Candidate

Amsterdam UMC, location VUmc

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