Clinical trial NCT06345547: Muscle Mass Via UltraSound in Cirrhosis (MMUSCLE)
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcopenia
Cirrhosis
Malnutrition
Keywords: sarcopenia
cirrhosis
malnutrition
skeletal muscle ultrasound
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From our large population we will prospectively evaluate 60 patients with all 3 muscle parameters (US m quadriceps, US m thenar and hand grip strength). This will allow to calculate the incidence rate and relative risk of sarcopenia presence in this population. To keep the population homogeneous we will include patients according to the Child-Pugh classification with a balanced distribution between the subclasses.

Brief summary: 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:

* what is the prevalence and development of sarcopenia in cirrhosis?
* what is the role of malnutrition? Participants will

  * undergo a muscle ultrasound of the lower and upper limb muscles
  * handgrip strength will be measured
  * malnutrition screening and assessment
  * complete a questionnaire to assess quality of life

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* diagnosis of cirrhosis and follow-up in the University Hospital of Antwerp

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prevalence of sarcopenia: muscle mass
timeFrame: baseline
measure: Prevalence of sarcopenia: muscle strength
timeFrame: baseline
measure: Development of sarcopenia: changes in muscle mass
timeFrame: 2 years
measure: Development of sarcopenia: changes in muscle strength
timeFrame: 2 years
measure: Development of sarcopenia: changes in muscle quality
timeFrame: 2 years
Secondary outcomes:
measure: Decompensation events: MELD score • MELD evolution
timeFrame: 2 years
measure: Decompensation events: mortality • MELD evolution
timeFrame: 2 years
measure: Decompensation events: transplantation • MELD evolution
timeFrame: 2 years
measure: Malnutrition
timeFrame: 2 years
measure: Quality of life in cirrhosis
timeFrame: 2 years
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerpen
Study officials:
affiliation: University Hospital, Antwerp
name: Karolien Dams, MD
role: PRINCIPAL_INVESTIGATOR
References:
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