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NCT Number: NCT04502719

Comparison of Nutritional Screening Tools in Liver Cirrhosis Patients

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional screening.

Diagnostic Test

Nutritional screening with the RFH-NPT and LDUST questionnaires.

Primary outcomes

  1. Malnutrition diagnostic concordance.

    Time frame: 48 hours

    Diagnostic concordance between nutritional screening questionnaires and nutritional assessment using GLIM criteria

Secondary outcomes

  1. Malnutrition prevalence.

    Time frame: 48 hours.

    Prevalence of malnutrition according to the GLIM criteria.

  2. Sarcopenia prevalence.

    Time frame: 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.

  3. Quality of life score.

    Time frame: 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.

  4. Adverse clinical outcomes.

    Time frame: 6 months.

    Number of adverse clinical outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Joan Trabal, RDN, PhD

CONTACT

[email protected]

+342275400 ext. 2388

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2020
Registry last updated
Dec 3, 2024

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.

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