Muscle Mass Via UltraSound in Cirrhosis (MMUSCLE)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of cirrhosis and follow-up in the University Hospital of Antwerp
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ultrasound
Other interventionUltrasound of m. quadriceps and m. thenar All ultrasound measurements will be performed in triplicate, with the average of the scores used in final analyses. Four parameters will be evaluated: muscle thickness, muscle cross sectional area, pennation angle and echo intensity (gain, depth and frequency will be kept constant). Hand grip strength measurement: measurement by an electronic hand dynamometer DynEx1TM (MD Systems, Inc. Ohio, USA). The recommendations for the handgrip strength test of the American Society of Hand Therapists will be followed: The maximum of the three values will be considered for analysis.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Child A1 intervention
Group B: Child B1 intervention
Group C: Child C1 intervention
Trial outcomes
Primary outcomes
1
Prevalence of sarcopenia: muscle mass
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.
Time frame
baseline2
Prevalence of sarcopenia: muscle strength
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.
Time frame
baseline3
Development of sarcopenia: changes in muscle mass
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.)
Time frame
2 years4
Development of sarcopenia: changes in muscle strength
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.
Time frame
2 yearsSecondary outcomes
1
Decompensation events: MELD score • MELD evolution
clinical evolution of cirrhosis: MELD (Model of Endstage Liver Disease) score in points (range 7-40), with a higher score defining a worse state.
Time frame
2 years2
Decompensation events: mortality • MELD evolution
clinical evolution of cirrhosis: Mortality 1 year after enrolment (Y/N)
Time frame
2 years3
Decompensation events: transplantation • MELD evolution
clinical evolution of cirrhosis: Need for transplantation/transplant outcome (Y/N)
Time frame
2 years4
Malnutrition
The European Society for Clinical Nutrition and Metabolism guidelines recommend the Royal Free Hospital-Nutritional Prioritizing Tool (RFH-NPT) to identify malnutrition risk in patients with liver disease. The RFH-NPT categorises nutritional risk as low (0 points), medium (1 points) and high (2-7 points). The Global Leadership Initiative on Malnutrition (GLIM) has established a global consensus on the criteria for diagnosing malnutrition in adults in hospital settings. It is a two-step approach for the malnutrition diagnosis, i.e., first screening to identify "at risk" status by the use of any validated screening tool, and second, assessment for diagnosis and grading the severity of malnutrition; mild - moderate - severe.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov