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Comparison of Nutritional Screening Tools in Liver Cirrhosis Patients

Comparison of Two Nutritional Screening Tools for the Detection of Malnutrition in Patients with Liver Cirrhosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04502719
Enrollment
46
Registered
2020-08-06
Start date
2021-02-22
Completion date
2025-12-31
Last updated
2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Liver, Malnutrition

Keywords

malnutrition, liver cirrhosis, sarcopenia, quality of life

Brief summary

This study compares two nutritional screening questionnaires in cirrhotic patients. All patients will be assessed with both questionnaires, besides a complete nutritional assessment.

Detailed description

Disease-related malnutrition is a health problem with high prevalence and associated costs. Poor nutritional status has an unfavorable effect on clinical outcomes in terms of complications, post-transplant survival and mortality in relation to the liver, in addition to a decrease in quality of life. The same complications of liver disease, such as hypoalbuminemia or ascites, make it difficult to assess malnutrition in cirrhotic patients. The use of screening tools defines the first step in the prevention and treatment of patients at risk of malnutrition or overt malnutrition. The use of screening tools to detect malnutrition upon admission to hospital improves the identification of malnourished patients by 50-80%, early treatment of patients can reduce hospital stay. It has been observed that nutritional interventions, after assessment of nutritional risk, appear to prevent complications and improve quality of life and survival rate in cirrhotic patients. Due to changes in body composition in cirrhotic patients (i.e. ascites), the most common questionnaires for screening for malnutrition (e.g. MUST, NRS-2002), which use anthropometric measures, have not been validated in cirrhosis and are therefore not considered suitable for malnutrition screening. On the contrary, in recent years two specific nutritional screening tools have been developed for cirrhotic patients, the Royal Free Hospital Nutritional Prioritizing Tool (RFH-NPT) and the Liver Disease Undernutrition Screening Tool (LDUST). Both questionnaires, however, require further validation against clinical outcomes in cirrhotic patients. This study will use two screening tools for malnutrition risk (RFH-NPT and LDUST), to compare their validity in detecting malnutrition risk in patients with liver cirrhosis. These tools will be validated by performing a nutritional assessment with the new diagnostic criteria of malnutrition promoted by the Global Leadership Initiative on Malnutrition. Sarcopenia can occur in malnourished cirrhotic patients, so it will be of interest to know what the possible prevalence may be in the sample of patients studied. The use of the screening questionnaire SARC-F will allow an assessment of the prevalence of risk of sarcopenia. Situations such as malnutrition or sarcopenia can have an impact on the patient's health-related quality of life, so this parameter will be assessed using the Chronic Liver Disease Questionnaire.

Interventions

DIAGNOSTIC_TESTNutritional screening.

Nutritional screening with the RFH-NPT and LDUST questionnaires.

Sponsors

Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Patients diagnosed with liver cirrhosis.

Exclusion criteria

* Patients with cognitive impairment or major psychiatric disorder. * Lack of consent from the patient for inclusion in the study. * Any patient who is not suitable based on the researcher's own judgement.

Design outcomes

Primary

MeasureTime frameDescription
Malnutrition diagnostic concordance.48 hoursDiagnostic concordance between nutritional screening questionnaires and nutritional assessment using GLIM criteria

Secondary

MeasureTime frameDescription
Malnutrition prevalence.48 hours.Prevalence of malnutrition according to the GLIM criteria.
Sarcopenia prevalence.48 hours.Prevalence of the risk of sarcopenia assessed with the SARC-F (Strength, Assistance, Rise, Climb-Falls) questionnaire. Minimum and maximum values: 0-10. Higher scores mean a worse outcome.
Quality of life score.48 hours.Quality of life score according to the Chronic Liver Disease Questionnaire (CLDQ). Minimum and maximum values: 5-36. Higher scores mean a better outcome.
Adverse clinical outcomes.6 months.Number of adverse clinical outcomes.

Countries

Spain

Contacts

Primary ContactJoan Trabal, RDN, PhD
jtrabal@clinic.cat+342275400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026