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临床试验/NCT05834894
NCT05834894进行中(未招募)不适用

Does Muscle Mass At Intensive Care Unit Admission Determine Mortality: the Memo Study

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
4,000
试验地点
1
主要终点
30-day mortality

研究概览

简要总结

This retrospective monocentric study aims to investigate whether a low muscle mass at ICU admission and its loss over the ICU stay predicts mortality, and in what proportion we can counteract it by nutritional support.

详细描述

The study hypothesis is that a low muscle mass at ICU admission, measured at the level of L3 on CT scans performed for clinical routine, and its change over the ICU stay predict the prognosis of the patient, especially the 30-day mortality, that it may at least be partly counteracted by nutritional support and that it is related with higher ICU and hospital costs.

The objectives of this retrospective study are to determine:

  1. the link between baseline body composition at ICU admission and outcomes, such as 30-day, ICU and hospital mortality and LOS, and infections. If this is confirmed, we aim to evaluate the added values of body composition to ICU severity scores to predict 30-day mortality
  2. the link between baseline body composition vs. other locations to predict outcomes
  3. the impact of body composition changes on the afore-mentioned outcomes. If this is confirmed, we aim to evaluate the added value of changes in body composition to changes in ICU severity scores to predict 30-day mortality
  4. the impact of nutritional support on body composition changes

研究设计

研究类型
Observational
观察模型
Other
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

  • Associations of baseline body composition with clinical outcomes:
  • Adults ≥ 18 yrs, hospitalized in the ICU of the HUG between January 1st 2010 and December 31st 2022 and Abdominal, or thoraco-abdominal CT scan measured 48 hours before to 96 hours after ICU admission in the HUG
  • Associations of body composition changes with clinical outcomes, nutritional support or medico-economic paratemers:
  • Identical as for the associations of baseline body composition with clinical outcomes and At least one additional CT performed during the hospital stay

排除标准

  • Associations of baseline body composition with clinical outcomes:
  • CT scans of low quality or CT scans performed outside of the HUG or Presence of a documented refusal
  • Associations of body composition changes with clinical outcomes, nutritional support or medico-economic paratemers:
  • Additionnally: oral nutrition, because we cannot assess the quantity and composition of oral intakes retrospectively

结局指标

主要结局

30-day mortality

时间窗: 30-day mortality between January 1st 2010 and December 31st 2022.

Association between skeletal muscle index (SMI) at the L3 vertebra level (psoas + abdominal wall muscles + paraspinal muscles), measured from 48 hours before to 96 hours after ICU admission, with 30-day mortality.

次要结局

  • Association of body composition changes with outcomes(Day 30)
  • Association of body composition changes with nutritional support(Day 30)
  • Association of muscle loss with medico-economical parameters(Day 30)
  • Association of baseline body composition at ICU admission with other outcomes(30-day)
  • Association of baseline SMI at the L3 vertebra level vs. other locations to predict outcomes(Day 1 to day 30)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Genton Graf Laurence

Prof.

University Hospital, Geneva

研究点 (1)

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