Liver CirrhosisNCT05513651
Establishment of a Model for Predicting the Prognosis of HBV-related Decompensated Liver Cirrhosis Based on RFH-NPT
An observational study of Liver Cirrhosis and Malnutrition, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis, Malnutrition
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2016to 30 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Hospitalized patients with liver cirrhosis
Who cannot join
- Patients who refuse the follow-up of outpatient department
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital Xi'an Jiaotong University
Xi'an, Shannxi, 710061
About this study
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.
- Conditions
- Liver Cirrhosis, Malnutrition
- Keywords
- prediction, malnutrition, cirrhosis, prognosis
- Medical subject headings
- Liver Cirrhosis, Malnutrition, Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality is death caused by any cause.
Measured: 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.
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Jul 2016
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513651
- Sponsor's protocol ID
- XJTU1AF-CRF-2020-023
- Status last verified
- Dec 2023
- First submitted
- 22 Aug 2022
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Model for Predicting the Prognosis of HBV-related Decompensated Liver Cirrhosis Based on RFH-NPT
- ClinicalTrials.gov ID
- NCT05513651
- Acronym / sponsor ID
- XJTU1AF-CRF-2020-023
- Conditions
- Liver Cirrhosis, Malnutrition
- Keywords
- prediction, malnutrition, cirrhosis, prognosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Hospitalized patients with liver cirrhosis
Key exclusion criteria (1 listed)
- Patients who refuse the follow-up of outpatient department
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: up to 10 years
All-cause mortality is death caused by any cause.
Liver-related mortality
Time frame: up to 10 years
Liver-related mortality refers to death from any liver-related disease, such as liver cirrhosis, liver cancer and other related complications.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Derived from this study: PubMed 40731156Zhu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Malnutrition, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: up to 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05513651, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.