Muscle Mass Via UltraSound in Cirrhosis (MMUSCLE)

Antwerp University Hospital (UZA)

Status: Enrolling

Conditions: Malnutrition; Cirrhosis; Sarcopenia

Treatments: Other: ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT06345547

EDGE 003539

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

Child A

Description:

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.

Treatment:

Other: ultrasound

Child B

Description:

Child B patients have a moderately impaired hepatic function.

Treatment:

Other: ultrasound

Child C

Description:

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)

Treatment:

Other: ultrasound