<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04502719</url>
  </required_header>
  <id_info>
    <org_study_id>NUSCIR-20</org_study_id>
    <nct_id>NCT04502719</nct_id>
  </id_info>
  <brief_title>Comparison of Nutritional Screening Tools in Liver Cirrhosis Patients</brief_title>
  <official_title>Comparison of Two Nutritional Screening Tools for the Detection of Malnutrition in Patients With Liver Cirrhosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Clinic of Barcelona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares two nutritional screening questionnaires in cirrhotic patients. All&#xD;
      patients will be assessed with both questionnaires, besides a complete nutritional&#xD;
      assessment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Disease-related malnutrition is a health problem with high prevalence and associated costs.&#xD;
      Poor nutritional status has an unfavorable effect on clinical outcomes in terms of&#xD;
      complications, post-transplant survival and mortality in relation to the liver, in addition&#xD;
      to a decrease in quality of life. The same complications of liver disease, such as&#xD;
      hypoalbuminemia or ascites, make it difficult to assess malnutrition in cirrhotic patients.&#xD;
&#xD;
      The use of screening tools defines the first step in the prevention and treatment of patients&#xD;
      at risk of malnutrition or overt malnutrition. The use of screening tools to detect&#xD;
      malnutrition upon admission to hospital improves the identification of malnourished patients&#xD;
      by 50-80%, early treatment of patients can reduce hospital stay. It has been observed that&#xD;
      nutritional interventions, after assessment of nutritional risk, appear to prevent&#xD;
      complications and improve quality of life and survival rate in cirrhotic patients.&#xD;
&#xD;
      Due to changes in body composition in cirrhotic patients (i.e. ascites), the most common&#xD;
      questionnaires for screening for malnutrition (e.g. MUST, NRS-2002), which use anthropometric&#xD;
      measures, have not been validated in cirrhosis and are therefore not considered suitable for&#xD;
      malnutrition screening. On the contrary, in recent years two specific nutritional screening&#xD;
      tools have been developed for cirrhotic patients, the Royal Free Hospital Nutritional&#xD;
      Prioritizing Tool (RFH-NPT) and the Liver Disease Undernutrition Screening Tool (LDUST). Both&#xD;
      questionnaires, however, require further validation against clinical outcomes in cirrhotic&#xD;
      patients.&#xD;
&#xD;
      This study will use two screening tools for malnutrition risk (RFH-NPT and LDUST), to compare&#xD;
      their validity in detecting malnutrition risk in patients with liver cirrhosis. These tools&#xD;
      will be validated by performing a nutritional assessment with the new diagnostic criteria of&#xD;
      malnutrition promoted by the Global Leadership Initiative on Malnutrition.&#xD;
&#xD;
      Sarcopenia can occur in malnourished cirrhotic patients, so it will be of interest to know&#xD;
      what the possible prevalence may be in the sample of patients studied. The use of the&#xD;
      screening questionnaire SARC-F will allow an assessment of the prevalence of risk of&#xD;
      sarcopenia. Situations such as malnutrition or sarcopenia can have an impact on the patient's&#xD;
      health-related quality of life, so this parameter will be assessed using the Chronic Liver&#xD;
      Disease Questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 22, 2021</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Malnutrition diagnostic concordance.</measure>
    <time_frame>48 hours</time_frame>
    <description>Diagnostic concordance between nutritional screening questionnaires and nutritional assessment using GLIM criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Malnutrition prevalence.</measure>
    <time_frame>48 hours.</time_frame>
    <description>Prevalence of malnutrition according to the GLIM criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sarcopenia prevalence.</measure>
    <time_frame>48 hours.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life score.</measure>
    <time_frame>48 hours.</time_frame>
    <description>Quality of life score according to the Chronic Liver Disease Questionnaire (CLDQ). Minimum and maximum values: 5-36. Higher scores mean a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse clinical outcomes.</measure>
    <time_frame>6 months.</time_frame>
    <description>Number of adverse clinical outcomes.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Malnutrition</condition>
  <condition>Cirrhosis, Liver</condition>
  <arm_group>
    <arm_group_label>Screened</arm_group_label>
    <description>Patients with liver cirrhosis screened for malnutrition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Nutritional screening.</intervention_name>
    <description>Nutritional screening with the RFH-NPT and LDUST questionnaires.</description>
    <arm_group_label>Screened</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The cohort will be selected from admitted patients at the Hepatology ward of the Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with liver cirrhosis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cognitive impairment or major psychiatric disorder.&#xD;
&#xD;
          -  Lack of consent from the patient for inclusion in the study.&#xD;
&#xD;
          -  Any patient who is not suitable based on the researcher's own judgement.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joan Trabal, RDN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joan Trabal, RDN, PhD</last_name>
    <phone>+342275400</phone>
    <phone_ext>2388</phone_ext>
    <email>jtrabal@clinic.cat</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <state>Catalonia</state>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>23848119</PMID>
  </reference>
  <reference>
    <citation>Iwasa 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.</citation>
    <PMID>24103520</PMID>
  </reference>
  <reference>
    <citation>Tandon 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.</citation>
    <PMID>28027577</PMID>
  </reference>
  <reference>
    <citation>Cederholm 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.</citation>
    <PMID>30181091</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>March 18, 2022</last_update_submitted>
  <last_update_submitted_qc>March 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
    <investigator_full_name>Joan Trabal</investigator_full_name>
    <investigator_title>RDN, PhD</investigator_title>
  </responsible_party>
  <keyword>malnutrition</keyword>
  <keyword>liver cirrhosis</keyword>
  <keyword>sarcopenia</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04502719
org study id: NUSCIR-20
nct id: NCT04502719
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study compares two nutritional screening questionnaires in cirrhotic patients. All
      patients will be assessed with both questionnaires, besides a complete nutritional
      assessment.
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: Malnutrition diagnostic concordance.
time frame: 48 hours
description: Diagnostic concordance between nutritional screening questionnaires and nutritional assessment using GLIM criteria
measure: Malnutrition prevalence.
time frame: 48 hours.
description: Prevalence of malnutrition according to the GLIM criteria.
measure: Sarcopenia prevalence.
time frame: 48 hours.
description: 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.
measure: Quality of life score.
time frame: 48 hours.
description: Quality of life score according to the Chronic Liver Disease Questionnaire (CLDQ). Minimum and maximum values: 5-36. Higher scores mean a better outcome.
measure: Adverse clinical outcomes.
time frame: 6 months.
description: Number of adverse clinical outcomes.
arm group label: Screened
description: Patients with liver cirrhosis screened for malnutrition.
intervention type: Diagnostic Test
intervention name: Nutritional screening.
description: Nutritional screening with the RFH-NPT and LDUST questionnaires.
arm group label: Screened
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Joan Trabal, RDN, PhD
role: Principal Investigator
affiliation: Hospital Clinic of Barcelona
last name: Joan Trabal, RDN, PhD
phone: +342275400
phone ext: 2388
email: jtrabal@clinic.cat
facility: 
status: Recruiting
country: Spain
citation: 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.
PMID: 23848119
citation: Iwasa 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.
PMID: 24103520
citation: Tandon 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.
PMID: 28027577
citation: Cederholm 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.
PMID: 30181091
responsible party type: Principal Investigator
investigator affiliation: Hospital Clinic of Barcelona
investigator full name: Joan Trabal
investigator title: RDN, PhD
mesh term: Liver Cirrhosis
mesh term: Malnutrition
mesh term: Fibrosis
sharing ipd: No