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临床试验/NCT03709498
NCT03709498已完成不适用

Nutritional Status as a Prognostic Marker of Risk and Outcome in Patients Admitted to Hospital With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Evangelismos Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年1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
60
试验地点
1
主要终点
Phase Angle

研究概览

简要总结

A cross sectional observation study of body composition in COPD patients consecutively hospitalized with acute exacerbation.

详细描述

Skeletal muscle dysfunction and changes in body composition are important extra-pulmonary manifestations of chronic obstructive pulmonary disease (COPD) that occur in all stages of disease and are associated with poor outcome. In patients with COPD, bioelectrical impedance analysis (BIA) has usually been used to estimate fat-free mass (FFM) and body composition through predictive equations. Very few studies had focused on raw BIA data. The aim of this study is first describe the measurement of phase angle in patients with with acute exacerbation and second to determine the validity of phase angle in this group by assessing its relationship with established markers of function, disease severity and prognosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Previous diagnosis of COPD based on history
  • Hospitalization with acute COPD exacerbation

排除标准

  • Patients with history of recent surgery (major) and trauma (major)
  • Patients with concomitant disease that might alter nutritional status (heart disease, cirrhosis, uncontrolled diabetes, chronic renal failure, uncontrolled cor pulmonale).
  • Contraindication to BIA including an implanted pacemaker, defibrillator or joint prosthesis

结局指标

主要结局

Phase Angle

时间窗: 1 month

The evaluation of phase angle will be performed by means of the electric bioimpedance apparatus. The measurements will be obtained with the patient in dorsal decubitus, barefoot, with the lower limbs slightly apart and without metal objects attached to the body, with electrodes placed on the right hand and foot.

次要结局

  • Forced expiratory flow volume in one second (FEV1).(1 month)
  • Length of Hospital Stay (LOS)(1 month)
  • Body Composition(1 month.)
  • Change in Forced vital capacity (FVC)(1 month)
  • Correlation between phase angle and serum CRP levels.(1 month)
  • Phase Angle(2 months)

研究者

发起方
Evangelismos Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dimitrios Karayiannis

Clinical Dietitian, Department of Clinical Nutrition and Metabolism

Evangelismos Hospital

研究点 (1)

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