Comparison of Nutritional Screening Tools in Liver Cirrhosis Patients

Recruiting

• Conditions: Malnutrition; Cirrhosis, Liver
• Interventions: Diagnostic Test: Nutritional screening.

• Registration Number: NCT04502719
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Study Timeline

• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-06
• Study Start: 2021-02-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Screened	Nutritional screening.	Patients with liver cirrhosis screened for malnutrition.

Primary Outcome Measures

Name	Time	Method
Malnutrition diagnostic concordance.	48 hours	Diagnostic concordance between nutritional screening questionnaires and nutritional assessment using GLIM criteria

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Catalonia, Spain