NCT05513651

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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

Study Progress68%
Jul 2016Dec 2030

Study Start

First participant enrolled

July 1, 2016

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Expected
Last Updated

April 3, 2024

Status Verified

December 1, 2023

Enrollment Period

9.5 years

First QC Date

August 22, 2022

Last Update Submit

April 2, 2024

Conditions

Keywords

predictionmalnutritioncirrhosisprognosis

Outcome Measures

Primary Outcomes (2)

  • All-cause mortality

    All-cause mortality is death caused by any cause.

    up to 10 years

  • Liver-related mortality

    Liver-related mortality refers to death from any liver-related disease, such as liver cirrhosis, liver cancer and other related complications.

    up to 10 years

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalized patients with liver cirrhosis were recruited. In addition, healthy volunteers who had normal liver function and normal BMI were recruited and acted as controls.

You may qualify if:

  • Hospitalized patients with liver cirrhosis

You may not qualify if:

  • Patients who refuse the follow-up of outpatient department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital Xi'an Jiaotong University

Xi'an, Shannxi, 710061, China

Location

Related Publications (1)

  • Zhu C, Wu Y, Zhao F, Wang R, Zang Q, Jiao Z, Zhu Y, Yan T, Du J, Zhu L, Li W, Li Y, Fan Q, Wu A, Liu X, Liu D, Tang X, Xu X, Liao H, Li Y, Zhao Y, He Y, Yang Y. An RFH-NPT-based nomogram for predicting the long-term survival of liver cirrhosis patients: a multicenter study. Eur J Clin Nutr. 2025 Jul 29. doi: 10.1038/s41430-025-01648-4. Online ahead of print.

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Liver CirrhosisMalnutritionFibrosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 24, 2022

Study Start

July 1, 2016

Primary Completion

December 30, 2025

Study Completion (Estimated)

December 30, 2030

Last Updated

April 3, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations