MalnutritionNCT04502719
Comparison of Nutritional Screening Tools in Liver Cirrhosis Patients
An observational study of Malnutrition and Cirrhosis, Liver, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
This study compares two nutritional screening questionnaires in cirrhotic patients. All patients will be assessed with both questionnaires, besides a complete nutritional assessment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Malnutrition, Cirrhosis, Liver
- What is being tested?
- Nutritional screening.
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 22 Feb 2021to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The cohort will be selected from admitted patients at the Hepatology ward of the Hospital.
Who may be able to join
- Patients diagnosed with liver cirrhosis.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic de Barcelona
Barcelona, Catalonia, 08036
About this study
Official title: Comparison of Two Nutritional Screening Tools for the Detection of Malnutrition in Patients with Liver Cirrhosis
This study compares two nutritional screening questionnaires in cirrhotic patients. All patients will be assessed with both questionnaires, besides a complete nutritional assessment.
Read the 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.
- Conditions
- Malnutrition, Cirrhosis, Liver
- Being tested
- Nutritional screening.
- Keywords
- malnutrition, liver cirrhosis, sarcopenia, quality of life
- Medical subject headings
- Malnutrition, Liver Cirrhosis, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional screening.Diagnostic test
Nutritional screening with the RFH-NPT and LDUST questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Screened | Patients with liver cirrhosis screened for malnutrition. Receives: Diagnostic Test: Nutritional screening. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malnutrition diagnostic concordance.
Diagnostic concordance between nutritional screening questionnaires and nutritional assessment using GLIM criteria
Measured: 48 hours
Secondary outcomes (4)
Malnutrition prevalence.
Prevalence of malnutrition according to the GLIM criteria.
Measured: 48 hours.
Sarcopenia prevalence.
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.
Measured: 48 hours.
Quality of life score.
Quality of life score according to the Chronic Liver Disease Questionnaire (CLDQ). Minimum and maximum values: 5-36. Higher scores mean a better outcome.
Measured: 48 hours.
Adverse clinical outcomes.
Number of adverse clinical outcomes.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start22 Feb 2021
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Trabal, Hospital Clinic of Barcelona
- Investigators
- Joan Trabal, RDN, PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502719
- Sponsor's protocol ID
- NUSCIR-20
- Status last verified
- Nov 2024
- First submitted
- 4 Aug 2020
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferreira LG, Anastacio LR, Lima AS, Touslon Davisson Correia MI. Predictors of mortality in patients on the waiting list for liver transplantation. Nutr Hosp. 2013 May-Jun;28(3):914-9. doi: 10.3305/nh.2013.28.3.6333.
PubMed 23848119Iwasa M, Iwata K, Hara N, Hattori A, Ishidome M, Sekoguchi-Fujikawa N, Mifuji-Moroka R, Sugimoto R, Fujita N, Kobayashi Y, Takei Y. Nutrition therapy using a multidisciplinary team improves survival rates in patients with liver cirrhosis. Nutrition. 2013 Nov-Dec;29(11-12):1418-21. doi: 10.1016/j.nut.2013.05.016.
PubMed 24103520Tandon P, Raman M, Mourtzakis M, Merli M. A practical approach to nutritional screening and assessment in cirrhosis. Hepatology. 2017 Mar;65(3):1044-1057. doi: 10.1002/hep.29003. Epub 2017 Feb 6.
PubMed 28027577Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee; GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3.
PubMed 30181091
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Nutritional Screening Tools for the Detection of Malnutrition in Patients with Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT04502719
- Acronym / sponsor ID
- NUSCIR-20
- Conditions
- Malnutrition, Cirrhosis, Liver
- Keywords
- malnutrition, liver cirrhosis, sarcopenia, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screened | – | Diagnostic Test: Nutritional screening.Patients with liver cirrhosis screened for malnutrition. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort will be selected from admitted patients at the Hepatology ward of the Hospital.
Key inclusion criteria (1 listed)
- Patients diagnosed with liver cirrhosis.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional screening.Nutritional screening with the RFH-NPT and LDUST questionnaires. | Diagnostic test | Screened |
Primary outcome
Malnutrition diagnostic concordance.
Time frame: 48 hours
Diagnostic concordance between nutritional screening questionnaires and nutritional assessment using GLIM criteria
4 secondary outcomes
Malnutrition prevalence.
Time frame: 48 hours.
Sarcopenia prevalence.
Time frame: 48 hours.
Quality of life score.
Time frame: 48 hours.
Adverse clinical outcomes.
Time frame: 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Background: PubMed 23848119Ferreira LG, Anastacio LR, Lima AS, Touslon Davisson Correia MI. Predictors of mortality in patients on the waiting list for liver transplantation. Nutr Hosp. 2013 May-Jun;28(3):914-9. doi: 10.3305/nh.2013.28.3.6333.
- Background: PubMed 24103520Iwasa M, Iwata K, Hara N, Hattori A, Ishidome M, Sekoguchi-Fujikawa N, Mifuji-Moroka R, Sugimoto R, Fujita N, Kobayashi Y, Takei Y. Nutrition therapy using a multidisciplinary team improves survival rates in patients with liver cirrhosis. Nutrition. 2013 Nov-Dec;29(11-12):1418-21. doi: 10.1016/j.nut.2013.05.016.
- Background: PubMed 28027577Tandon P, Raman M, Mourtzakis M, Merli M. A practical approach to nutritional screening and assessment in cirrhosis. Hepatology. 2017 Mar;65(3):1044-1057. doi: 10.1002/hep.29003. Epub 2017 Feb 6.
- Background: PubMed 30181091Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee; GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joan Trabal, RDN, PhD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Cirrhosis, Liver, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joan Trabal, RDN, PhD (+342275400 ext. 2388, jtrabal@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malnutrition diagnostic concordance. (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04502719, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.