NCT04502719

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

4.3 years

First QC Date

August 4, 2020

Last Update Submit

November 29, 2024

Conditions

MalnutritionCirrhosis, Liver

Keywords

malnutritionliver cirrhosissarcopeniaquality of life

Outcome Measures

Primary Outcomes (1)

  • Malnutrition diagnostic concordance.

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

    48 hours

Secondary Outcomes (4)

  • Malnutrition prevalence.

    48 hours.

  • Sarcopenia prevalence.

    48 hours.

  • Quality of life score.

    48 hours.

  • Adverse clinical outcomes.

    6 months.

Study Arms (1)

Screened

Patients with liver cirrhosis screened for malnutrition.

Diagnostic Test: Nutritional screening.

Interventions

Nutritional screening.DIAGNOSTIC_TEST

Nutritional screening with the RFH-NPT and LDUST questionnaires.

Screened

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The cohort will be selected from admitted patients at the Hepatology ward of the Hospital.

You may qualify if:

  • Patients diagnosed with liver cirrhosis.

You may not qualify if:

  • Patients with cognitive impairment or major psychiatric disorder.
  • Any patient who is not suitable based on the researcher's own judgement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

RECRUITING

Related Publications (4)

  • 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: 23848119BACKGROUND

  • 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: 24103520BACKGROUND

  • 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: 28027577BACKGROUND

  • 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: 30181091BACKGROUND

MeSH Terms

Conditions

MalnutritionLiver CirrhosisSarcopenia

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesLiver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Study Officials

  • Joan Trabal, RDN, PhD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joan Trabal, RDN, PhD

CONTACT

+342275400jtrabal@clinic.cat

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RDN, PhD

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 6, 2020

Study Start

February 22, 2021

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

December 3, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)