The Influence of Nutritional Factors on the Prognosis of Liver Cirrhosis Patients and the Exploration of Predictive Models

NCT06328517 | Recruiting

• 1 other identifier: 2023-305
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Cirrhosis is a progressive developing liver disease transforming normal hepatocytes into scar tissue with loss of function.The prevalence of cirrhosis has approximately tripled over the past two decades. With the increasing incidence of chronic liver disease, about 2 million people died from cirrhosis worldwide. Currently, D'Amico stage classification and Child-Pugh and Model for End-Stage Liver Disease (MELD) scores constitute the best tools to predict mortality in patients with Cirrhosis; however, one of their main limitations is the lack of evaluation of the nutritional and functional status. Patients with End-Stage Liver Disease (ESLD) have reduced nutritional intake, hypermetabolism, increased energy expenditure, impaired fasting adaptability, decreased hepatic glycogen reserves, and increased consumption of protein as the main energy donor that often lead to malnutrition, therefore, malnutrition is one of the most common complications in patients with Cirrhosis, is closely related to the increase in morbidity and mortality. Moreover, malnutrition is closely related to the high incidence of infection, ascites, hepatic encephalopathy, and hepatorenal syndrome, and is an independent risk factor affecting the survival rate of patients with End-Stage Liver Disease, including liver transplantation. Therefore, malnutrition should be treated as equally important complications such as ascites and hepatic encephalopathy, and accurate screening, evaluation and appropriate nutritional intervention measures should be taken to improve the prognosis of patients with Cirrhosis. This study aims to establish a nomogram model about nutritional factors to predict the prognosis of patients with Cirrhosis, verify and optimize the model, through the establishment of the model, to more comprehensively evaluate and predict the prognosis of patients with Cirrhosis from the perspective of nutrition, to provide sufficient basis and lay a solid foundation for further nutritional intervention and improve patient prognosis.

Conditions

Cirrhosis

Keywords

rest energy expenditure; malnutrition; prognosis

Outcome Measures

Primary Outcomes (1)

• Death

  Death due to cirrhosis progression

  January 2024 to November 2026

Secondary Outcomes (1)

• complication

  January 2024 to November 2026

Study Arms (1)

Patients with cirrhosis

Abdominal ultrasound, CT, or MRI showed Cirrhosis during the screening period; Fibroscan results during the screening period were\> 17.5kPa.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Abdominal ultrasound, CT, or MRI showed cirrhosis during the screening period; Fibroscan results during the screening period were\> 17.5kPa.

You may qualify if:

• Willing and able to sign an informed consent form;
• Abdominal ultrasound, CT, or MRI showed cirrhosis during the screening period; Fibroscan results during the screening period were\> 17.5kPa;
• Estimated survival time of more than 3 months;
• Full capacity for civil conduct.

You may not qualify if:

• The diagnosis of primary liver cancer or was supported by the following evidence: increased alpha-fetoprotein (AFP) (≥100 μg/L) for more than 3 months or liver imaging showed clear liver cancer nodules in the liver;
• A history of malignancy within 5 years prior to screening, except for specific cancers (such as basal cell skin cancer); current or prior history of major disease that may interfere with personal treatment, assessment or compliance. Major diseases are 25 major diseases as stipulated by the China Insurance Regulatory Commission;
• Severe lung disease, severe heart disease, diabetes mellitus, or genetic and metabolic diseases;
• Psychiatric hospitalization, attempted suicide, and / or temporary disability due to mental illness in the past five years;
• Pregnant or lactating women;
• The investigator considered not unsuitable for participants.

Sponsors & Collaborators

• Juan Kang: lead

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood

MeSH Terms

Conditions

Fibrosis; Malnutrition

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• juan Kang, M.D.

  The Second Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

Central Study Contacts

juan Kang, M.D.

CONTACT

8613996112052; 68368892@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 25, 2024
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

CN (1)