跳至主要内容
临床试验/NCT06829121
NCT06829121已完成不适用

Ultrasound-based Morphometry for the Development of Diagnostic and Prognostic Markers in Current and Chronic Diseases

Universitatsmedizin Mainz - 1. Medizinische Klinik1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
900
试验地点
1
主要终点
Complication

研究概览

简要总结

Frailty or debility is a geriatric syndrome that primarily affects older patients, but also patients with severe illnesses. It is particularly common among oncology patients, but also among patients with gastrointestinal diseases such as liver cirrhosis or pancreatitis. Sarcopenia, a component of frailty, is defined as a loss of muscle quantity, quality and function. Currently, complex methods such as CT or bioimpedance measurement are available. However, simpler techniques such as ultrasound-based measurement could be alternatives, but require further validation.

The aim of this project is to be able to estimate the prognosis of patients at an early stage by measuring sarcopenia using sonography.

详细描述

Frailty is a well-known syndrome that has a negative impact on many diseases and the course of disease. Patients affected by frailty are particularly vulnerable due to their inadequate ability to deal with extrinsic and intrinsic stress factors. The prevalence of frailty increases with age, affecting 15% of people over the age of 65 and 25% of people over the age of 80.

Frailty is the end result of an interplay between malnutrition, cognitive impairment and muscle wasting. Each of these factors can be further examined and measured, but they also influence each other. In particular, reduced muscle mass and muscle function have been associated with poor quality of life and a worse course of disease. Sarcopenia is therefore becoming an increasingly important factor in various disease patterns and should be monitored further. Muscle wasting and sarcopenia have multifactorial causes. Physical inactivity, chronic inflammation associated with chronic diseases, and malnutrition are particularly noteworthy in this context. Cross-sectional measurement of several muscles at the level of the lumbar vertebrae (L3), normalized to body size, and dual-energy X-ray absorptiometry are currently the most commonly used techniques for measuring sarcopenia. However, the measurements require complex equipment and procedures. In addition, radiological imaging is costly and causes radiation exposure. Therefore, attempts have been made in the past to simplify the measurements. Sonographic measurement is a practical alternative. Many different muscle groups are accessible to ultrasound. In particular, the thigh muscles and the psoas major muscle can be easily visualized sonographically. The sonographic assessment of the psoas muscle area index (PMAI) and the thigh muscle thickness index (TMTI) are approaches for bedside morphometry that the investigators use primarily.

Sarcopenia needs to be further investigated and included in the evaluation of therapeutic concepts. Recently, Zhang et al. showed that radiologically measured reduced psoas muscle mass was associated with poorer overall survival in HCC patients. Furthermore, it has been suggested several times that sarcopenia should be integrated into the MELD classification for liver transplantation. The investigators were also recently able to show in a cohort of COVID-19 patients that reduced muscle mass was associated with a poorer disease course during the pandemic.

The investigators expect sonographic measurements of the musculature to provide a better assessment of prognosis, quality of life and functional results under therapy.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All patients who receive a planned ultrasound examination as part of their outpatient or inpatient evaluation during the planned period.
  • •All patients over 18 years of age.

排除标准

  • •Patients under 18 years of age.
  • •Patients unable to give consent.
  • •Patients with neuromuscular disorders.

结局指标

主要结局

Complication

时间窗: From date of inclusion until the date of first documented decompensation or death from any cause, whichever came first, assessed up to two years

Number of participants with decompensation of the underlying disease (e.g. liver cirrhosis: hydropic decompensation) or death

次要结局

未报告次要终点

研究者

发起方
Universitatsmedizin Mainz - 1. Medizinische Klinik
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wolfgang Maximilian Kremer

Senior physician

Universitatsmedizin Mainz - 1. Medizinische Klinik

研究点 (1)

Loading locations...

相似试验