Clinical trial NCT03242798: Assessment of Nutritional Status of Patients With Liver Cirrhosis
Official title: Assessment of Nutritional Status of Patients With Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis
Malnutrition
Keywords: liver cirrhosis
malnutrition
nutritional status
nutritional assessment
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: Laikο General Hospital, Athens
First posted: 2017-08-08
Enrollment: 201
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: The study sample will comprise of 170 adults with biopsy proven cirrhosis visiting hospital Liver Outpatient Clinics in Athens, Greece.

Brief summary: Cirrhosis is the twelfth leading cause of death worldwide. Malnutrition is prevalent among cirrhotic patients and is an important prognostic factor. Nutritional assessment is therefore crucial for identifying patients at risk or with already established malnutrition and refer them for nutritional intervention and support. In the current literature, nutritional assessment of cirrhotic patients is performed using several tools and methods. However their accuracy is widely affected by the underline disease and its complications. In addition, for the majority of the parameters under study, no gold standard tools and methods have been established so far. Studies on nutritional assessment in cirrhosis usually focus on one or few aspects of nutritional status and not on a full nutritional assessment combining information from medical, biochemical, nutritional, and body composition variables. Hence, the present study aims at a thorough assessment of the nutritional status of 170 cirrhotic patients using multiple widely available tools and methods, in order to assess their accuracy and estimate the prevalence of multiple malnutrition phenotypes such as undernutrition, sarcopenia, sarcopenic obesity and cachexia.

Detailed description: The study sample will comprise of 170 adults with biopsy proven cirrhosis. A detailed medical and nutritional assessment will be implemented at baseline. For patients that will receive an intervention aiming at the cause of cirrhosis (e.g. antivirus therapy for HCV or HBV) the baseline assessment will take place before the beginning of the therapy and will be repeated three months after the completion of the medical intervention to explore the impact of the intervention on nutritional status. Data regarding the survival of all the patients will be collected one year after the baseline assessment.

More specifically regarding the detailed assessment, firstly, hepatologists of the research team will complete a full medical record regarding the primary disease, cirrhosis' complications, comorbidities and medication. The severity of cirrhosis will be assessed using the Child-Pugh score. Furthermore, in the Laboratory of Clinical Nutrition \& Dietetics at Harokopio University, patients will participate in the following procedures:

* Anthropometry: Weight, height, waist and mid-arm circumference, and triceps skinfold will be measured. Body mass index, mid-arm muscle circumference and area will be estimated using standard equations.
* Body composition analysis: Total body DXA (Lunar DPX-MD, Madison, WI, USA) will be performed.
* Muscle strength and performance status: Handgrip strength measurement based on certain protocol and the "Short Physical Performance Battery" tool will be implemented.
* Dietary intake evaluation: Three non-consecutive 24h recalls (two weekdays and one weekend day) will be recorded. Data will be analyzed to estimate energy, macro- and micronutrients intake (Nutritionist Pro software, 2.2 version). Food group intake and meal patterns will also be evaluated.
* Physical activity assessment: Patients' physical activity levels will be assessed using the "Harokopio Physical Activity Questionnaire".

For patients with available upper abdomen computed tomographies skeletal muscle index at L3 will be calculated with the software SliceOmatic V5.0 software, Tomovision, Montreal, PQ. In addition, patients' nutritional risk or nutritional status will be assessed through several previously validated tools like the Subjective Global Assessment, the Royal Free Hospital Global assessment scheme and Liver Disease Undernutrition Screening Tool, the efficacy of which will be tested in the present study. Patients will be also categorized according to ESPEN's recent malnutrition diagnostic criteria.

The full assessment will be repeated only for patients who will receive an intervention aiming at the cause of cirrhosis (e.g. antivirus therapy for HCV or HBV) three months after the completion of the medical intervention.

One year after the baseline assessment of the study samples, data will be collected regarding survival, development of complications and decompensated cirrhosis.

Eligibility criteria: Inclusion Criteria:

Adults with biopsy proven cirrhosis.

Exclusion Criteria:

Patients with hepatocellular carcinoma, in hepatic coma, with acquired immunodeficiency syndrome, with renal or pancreatic insufficiency, receiving enteral nutrition or being pregnant, will be excluded.

Primary outcomes:
measure: Prevalence of malnutrition phenotypes.
timeFrame: Baseline
Secondary outcomes:
measure: Survival.
timeFrame: One year after baseline measurements
measure: Validity test of available tools.
timeFrame: Baseline
measure: Nutritional status after medical treatment according to the etiology of cirrhosis.
timeFrame: 6 months after baseline measurements
Other outcomes:
Locations:
city: Kallithea
country: Greece
facility: Harokopio University
state: Attiki
Study officials:
affiliation: Harokopio University
name: Meropi D. Kontogianni, PhD
role: STUDY_DIRECTOR
References: