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临床试验/NCT02555670
NCT02555670已完成不适用

Relation Between Bioelectrical Impedance-derived Muscle Mass and CT-derived Muscle Area in Critically Ill Patients

Amsterdam UMC, location VUmc0 个研究点目标入组 222 人开始时间: 2014年5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
222
主要终点
Agreement between BIA-derived muscle mass and CT-derived muscle mass

研究概览

简要总结

Aim of the present study is to determine whether muscle mass as assessed by bioelectrical impedance analysis correlates with and corresponds to muscle mass as assessed by CT scan analysis in critically patients admitted to the intensive care unit.

详细描述

BIA measurements are performed in critically ill patients admitted to the ICU or MC, within 72 hours before or after CT scanning.

The BIA measurements are taken with the BIA 101 ASE, manufactured by Akern, Florence-7 Italy. This device is phase sensitive and injects an alternating current of 400 µA at 50 kHz. Measurements were performed while patients lay in supine position with a pillow supporting the head. The resistance, reactance, body weight and length are entered in the BIA algorithm, using BodyGram PRO. This algorithm calculated the body composition, with muscle mass being reported in kilogram (kg).

Abdominal CT scans are analyzed using the computer program SliceOmatic® version 4.3 and 5.0 (TomoVision, Montreal, QC, Canada) at the level of the third lumbar vertebra (L3). The muscle tissue was identified by using boundaries in Hounsfield Units (grayscale) set of -29 to +150(23). The program computes muscle surface area in cm2, by multiplying the pixel area by the amount of pixels identified as muscle.

For a direct comparison with the BIA-derived muscle mass, the CT-derived muscle area is converted to kg. This is done by following two steps. Firstly, the Shen equation is used for the conversion to litres.Secondly, the muscle volume is multiplied by its density, resulting in muscle mass expressed in kg.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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 CT-scan made for diagnostic reasons

排除标准

  • CT-scan not analysable
  • Internal or external metal devices
  • active pacemaker

结局指标

主要结局

Agreement between BIA-derived muscle mass and CT-derived muscle mass

时间窗: Patient's data from the ICU-stay will be used, an average of one week

Agreement will be calculated using a Bland-Altman plot

次要结局

  • Sensitivity of BIA to identify low muscle patients(Patient's data from the ICU-stay will be used, an average of one week)
  • Specificity of BIA to identify low muscle patients(Patient's data from the ICU-stay will be used, an average of one week)
  • Correlation between BIA-derived muscle mass and CT-derived muscle mass(Patient's data from the ICU-stay will be used, an average of one week)

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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