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Active, not recruitingNCT05513651Updated Apr 3, 2024

Establishment of a Model for Predicting the Prognosis of HBV-related Decompensated Liver Cirrhosis Based on RFH-NPT

An observational study in Liver Cirrhosis and Malnutrition, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Active, not recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-04-03.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Liver Cirrhosis
  • Malnutrition

Keywords

  • prediction
  • malnutrition
  • cirrhosis
  • prognosis
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In context

Liver Cirrhosis

1,668 studies on the registry are indexed under Liver Cirrhosis; 360 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 152 across 605 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 314 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hospitalized patients with liver cirrhosis

Exclusion criteria

Exclusion Criteria:

  • Patients who refuse the follow-up of outpatient department
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. All-cause mortality

    All-cause mortality is death caused by any cause.

    Time frame: up to 10 years

  2. Liver-related mortality

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

    Time frame: up to 10 years

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Study locations

1 site
  • First Affiliated Hospital Xi'an Jiaotong University
    Xi'an, Shannxi 710061, China
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References and documents

Publications

  • 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. 2026 Jan;80(1):87-95. doi: 10.1038/s41430-025-01648-4. Epub 2025 Jul 29. PubMed 40731156 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2016 (actual). Primary completion is estimated for Dec 2025, 113 months after the start.

Of 264 non-industry observational studies under Liver Cirrhosis, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 73. This study's planned 113 months is above that.

Counting every sponsor, half of 284 studies reached it within 42 months; a quarter within 17 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2022
First posted
Aug 24, 2022
StartActual
Jul 1, 2016
Primary completionEst.
Dec 30, 2025
CompletionEst.
Dec 30, 2030
Last update
Apr 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05513651
Responsible party
Sponsor
First posted
Aug 24, 2022
Start date
Jul 1, 2016
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2030 (estimated)
Last update
Apr 3, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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