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RecruitingNCT06328517

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
300 (estimated)
Sponsor
Juan Kang · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Detailed description

Patients with Cirrhosis attending the Second Affiliated Hospital of Chongqing Medical University were included in the retrospective study. Participants met the inclusion and exclusion criteria. The data to be collected include basic information including gender, age, height and weight; blood routine, liver and kidney function, coagulation function, abdominal CT / MRI, underlying disease, complications, treatment options, disease changes, etc; professional Resting Energy Expenditure (REE) measurement and regular follow-up. After the data collection, the effects of REE, albumin, 2,5-OH vitamin D, and muscle function on the long-term prognosis of the patients with Cirrhosis were investigated by drawing the survival curve, the Receiver-Operating Characteristic curve (ROC curve) , and the Area Under a ROC curve (AUC curve) .

Conditions

Timeline

Start date
2023-11-01
Primary completion
2026-11-01
Completion
2026-11-01
First posted
2024-03-25
Last updated
2025-06-25

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06328517. Inclusion in this directory is not an endorsement.