Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06328517 |
Other study ID # |
2023-305 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 1, 2023 |
Est. completion date |
November 1, 2026 |
Study information
Verified date |
March 2024 |
Source |
The Second Affiliated Hospital of Chongqing Medical University |
Contact |
juan Kang, M.D. |
Phone |
8613996112052 |
Email |
68368892[@]qq.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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) .