A Cohort Study on the Relationship Between Malnutrition and Prognosis in Patients With Liver Cirrhosis

Sponsor
First Affiliated Hospital Xi'an Jiaotong University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05513651
Collaborator
(none)
2,000
1
174
11.5

Study Details

Study Description

Brief Summary

For all countries, chronic liver disease and liver cirrhosis is one of the important disease burdens. Malnutrition is an important complication of liver cirrhosis, which always runs through the course of liver cirrhosis. According to a lot of scientific research evidence, as the consensus of experts all over the world, malnutrition in patients with liver cirrhosis is closely related to poor outcome. Therefore, early and accurate identification of the risk of malnutrition is very important to improve the prognosis of patients with liver cirrhosis.

The purpose of this study was to study the relationship between malnutrition-related indexes and prognosis in patients with liver cirrhosis. 2000 patients with liver cirrhosis were prospectively included, laboratory indexes related to malnutrition and other evaluation indexes were recorded, and long-term follow-up was made to observe the short-term and long-term prognosis of patients with liver cirrhosis. At the same time, a prognostic prediction model was established based on multivariate Cox regression, and a series of in-depth studies and verification were carried out on this basis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Malnutrition is one of the most common complications associated with liver cirrhosis, which is more likely to occur in patients with decompensated liver cirrhosis. Malnutrition will further lead to muscle loss, that is, the occurrence of myomyositis, which is an important cause of adverse outcome in patients with liver cirrhosis. it is associated with increased risk of death, portal hypertension-related complications, increased infection rates and longer hospital stays. At the same time, liver cirrhosis with portal hypertension leads to esophageal and gastric varices and intestinal mucosal edema, which affects the function of the digestive system and poses a greater challenge to the nutritional maintenance of patients with liver cirrhosis. Therefore, timely nutritional assessment and early intervention decision-making on admission is an important aspect of clinical management of patients with liver cirrhosis.

    For the screening of malnutrition in patients with liver cirrhosis, the commonly used screening tools are MST, MUST, NRS-2002, RFH-NPT and so on. For the screened high-risk population, further specific nutritional assessment is needed, there are four main types. The first is a diet-related assessment conducted by a professional dietitian. The second is the body composition analysis represented by muscle mass, such as bioelectrical impedance analysis (BIA), CT, ultrasound and so on. The third is the functional evaluation, of which the more common are five-meter walking speed and grip strength test. The fourth is part of the comprehensive evaluation tools, represented by SGA and RFH-SGA.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Cohort Study on the Relationship Between Malnutrition and Prognosis in Patients With Liver Cirrhosis
    Actual Study Start Date :
    Jul 1, 2016
    Anticipated Primary Completion Date :
    Dec 30, 2025
    Anticipated Study Completion Date :
    Dec 30, 2030

    Outcome Measures

    Primary Outcome Measures

    1. All-cause mortality [Up to 10 years]

      Death from any cause

    2. Liver-related mortality [Up to 10 years]

      Death from liver disease

    3. Acceptance of liver transplantation [Up to 10 years]

      Acceptance of liver transplantation

    Secondary Outcome Measures

    1. Liver-unrelated mortality [Up to 10 years]

      Death due to serious complications

    2. Accidental mortality [Up to 10 years]

      Death in accidents

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Hospitalized patients with liver cirrhosis
    Exclusion Criteria:
    • Patients who refuse the follow-up of outpatient department

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 First Affiliated Hospital Xi'an Jiaotong University Xi'an Shannxi China 710061

    Sponsors and Collaborators

    • First Affiliated Hospital Xi'an Jiaotong University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    First Affiliated Hospital Xi'an Jiaotong University
    ClinicalTrials.gov Identifier:
    NCT05513651
    Other Study ID Numbers:
    • XJTU1AF2020LSL-023
    First Posted:
    Aug 24, 2022
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by First Affiliated Hospital Xi'an Jiaotong University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 24, 2022