Prospective Observational Cohort Survey to Assess the Prevalence and Development of Sarcopenia and the Correlation of Muscle Mass and Outcome in Patients With Cirrhosis by Skeletal Muscle Ultrasound.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Development of sarcopenia: changes in muscle mass
研究概览
简要总结
The goal of this observational cohort study is to learn about loss of muscle mass and muscle strength (sarcopenia) in patients with cirrhosis. The main question[s] it aims to answer are:
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what is the prevalence and development of sarcopenia in cirrhosis?
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what is the role of malnutrition? Participants will
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undergo a muscle ultrasound of the lower and upper limb muscles
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handgrip strength will be measured
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malnutrition screening and assessment
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complete a questionnaire to assess quality of life
详细描述
In this study, the investigators will assess the prevalence and development of sarcopenia in the large in- and outpatient population with cirrhosis (n= 1346) of the University Hospital of Antwerp, using ultrasound assessment of muscle mass and quality in the lower as well as the upper limb muscles. Handgrip strength will be tested for muscle functional status. Findings will be correlated with clinical outcome (MELD, survival, decompensating events). The etiology of the cirrhosis and its underlying activity will be taken into account as dependent variables, e.g. whether there is a difference between compensated vs. decompensated cirrhosis. The investigators will screen for malnutrition using the RFH-NPT and compare with the GLIM criteria. The effect of sarcopenia on the quality of life will be evaluated using the validated "SarQoL®" (Sarcopenia Quality of Life) questionnaire.
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
- •diagnosis of cirrhosis and follow-up in the University Hospital of Antwerp
排除标准
- •known patient will against participation in the study or against the measures applied in the study
- •a decision made prior to inclusion to stop further treatment of the patient within the next 24 hours
- •no complete remission of malignancy including hepatocellular carcinoma within the past 12 months
研究组 & 干预措施
Child A
The impact of sarcopenia in patients with cirrhosis may also be influenced by sex, severity of hepatic dysfunction, and etiology of cirrhosis. For this reason we aim for an homogeneous population, with a balanced distribution over the Child Pugh classification with a homogeneous population of at least 50%.
Child A patients still have a good hepatic function.
干预措施: ultrasound (Other)
Child B
Child B patients have a moderately impaired hepatic function.
干预措施: ultrasound (Other)
Child C
Patients with Child C have an advanced hepatic dysfunction, within this group we will also look at patients with acute on chronic liver failure.(ACLF)
干预措施: ultrasound (Other)
结局指标
主要结局
Development of sarcopenia: changes in muscle mass
时间窗: 2 years
Changes in muscle mass by ultrasound muscle parameters from baseline up to 2 years follow-up. We will evaluate the muscle parameters that define muscle mass: muscle thickness expressed in cm, cross sectional area in squared cm, pennation angle in degrees and echo intensity expressed in arbitrary units (A.U.)
Prevalence of sarcopenia: muscle strength
时间窗: baseline
Number of patients with prevalent sarcopenia. This will be assessed by handgrip strength (expressed in kg). Sarcopenia has been defined by the European Working Group on Sarcopenia as "a progressive and generalized skeletal muscle disorder associated with an increased likelihood of adverse outcomes including falls, fractures, disability, and mortality," combining both muscle mass and muscle strength or muscle performance in its definition. As the definition contains both muscle mass and muscle strength, both factors have to be evaluated. This second outcome measure defines muscle strength.
Development of sarcopenia: changes in muscle quality
时间窗: 2 years
Changes in muscle mass by ultrasound muscle parameters from baseline up to 2 years follow-up. We will evaluate the muscle parameters that define quality of muscle: pennation angle in degrees and echo intensity expressed in arbitrary units (A.U.)
Development of sarcopenia: changes in muscle strength
时间窗: 2 years
This will be assessed by handgrip strength (expressed in kg). Sarcopenia has been defined by the European Working Group on Sarcopenia as "a progressive and generalized skeletal muscle disorder associated with an increased likelihood of adverse outcomes including falls, fractures, disability, and mortality," combining both muscle mass and muscle strength or muscle performance in its definition. As the definition contains both muscle mass and muscle strength, both factors have to be evaluated.
Prevalence of sarcopenia: muscle mass
时间窗: baseline
Number of patients with prevalent sarcopenia. This will be assessed by skeletal muscle ultrasound (muscle thickness expressed in cm). Sarcopenia has been defined by the European Working Group on Sarcopenia as "a progressive and generalized skeletal muscle disorder associated with an increased likelihood of adverse outcomes including falls, fractures, disability, and mortality," combining both muscle mass and muscle strength or muscle performance in its definition. This first outcome measure defines muscle mass.
次要结局
- Decompensation events: MELD score • MELD evolution(2 years)
- Decompensation events: transplantation • MELD evolution(2 years)
- Malnutrition(2 years)
- Quality of life in cirrhosis(2 years)
- Decompensation events: mortality • MELD evolution(2 years)
研究者
Karolien Dams
Principal Investigator, MD, senior staff intensive care
University Hospital, Antwerp