Harokopio University
Kallithea, Attica, 17671, Greece
NCT Number: NCT03242798
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Kallithea, Attica, 17671, Greece
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Time frame: Baseline
Prevalence of different malnutrition phenotypes (e.g. undernutrition, sarcopenia, sarcopenic obesity), in cirrhotic patients of different disease stages, by implementing a thorough nutritional assessment.
Time frame: One year after baseline measurements
Assessment of survival one year after baseline measurements and association with the malnutrition phenotypes at baseline.
Time frame: Baseline
Test the sensitivity, specificity, positive and negative prognostic values of already available tools for nutritional screening or assessment against a combined index as the reference tool. If no tool is estimated as valid, a new combination of nutritional, biochemical and/or clinical parameters will be synthesized and its validity as a new screening or assessment tool will be assessed for the detection of cirrhotic patients at risk of malnutrition or already malnourished.
Time frame: 6 months after baseline measurements
Changes in the nutritional status after medical treatment according to the etiology of cirrhosis, namely antivirus therapy for HCV or HBV cirrhosis, abstinence from alcohol in the alcoholic cirrhosis, immunosuppressive therapy in autoimmune cirrhosis.
Harokopio University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06593015
Atrophy, Behavior
Rome, Italy
View Trial DetailsNCT03285217
Atrophy, Cirrhosis
Zaragoza, Spain
View Trial DetailsNCT03458845
Atrophy, Cirrhosis
São Paulo, Brazil
View Trial DetailsNCT06345547
Atrophy, Cirrhosis
Edegem, Antwerpen, Belgium
View Trial Details