Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06279845 |
Other study ID # |
2023YFC2308802-02 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 2024 |
Est. completion date |
November 2026 |
Study information
Verified date |
March 2024 |
Source |
Zhejiang University |
Contact |
Jiajia Chen |
Phone |
+8615967109232 |
Email |
Jiajiatale0[@]zju.edu.cn |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The goal of this observational study is to expound the population and characteristics of
pathogenic microorganisms with co-infection, draw the pedigree of pathogenic microorganisms,
and evaluate its influence on disease outcome in patients with hepatic virus-caused
cirrhosis. The main questions it aims to answer are:
- Describe the populations and characteristics of pathogenic microorganisms responsible
for co-infections in patients with hepatic virus-caused cirrhosis.
- Map the spectrum of pathogenic microorganisms, and evaluate their impact on disease
regression.
Description:
Cirrhosis is a chronic progressive disease caused by different etiological factors and
characterized by diffuse hepatocellular degeneration and necrosis, abnormal regeneration of
hepatocytes, intrahepatic neovascularization, massive proliferation of hepatic fibrotic
tissues, and pseudofollicular formation. The number of patients with liver disease in China
is about 300 million, and the number of deaths from cirrhosis accounts for 11% of the global
deaths from cirrhosis. Its etiology is diverse, and hepatitis due to hepatophilic virus
infection is still the main cause in China. A recent study by scholars on 11861 patients
hospitalized for the first time due to liver cirrhosis in 50 hospitals in China showed that
among the causes of liver cirrhosis in China, HBV infection accounted for 71.15% and HCV
infection accounted for 8.12%. About two-thirds of patients with cirrhosis and extrahepatic
organ failure suffer from sepsis. Infections increase the risk of death in patients with
cirrhosis, and reports have shown that these patients are hospitalized for twice as long as
patients without cirrhotic sepsis and have a hospital mortality rate of up to 50%. This study
focuses on the impact of secondary infections on the clinical prognosis of cirrhosis, and
proposes to establish a prospective, multicenter clinical cohort of secondary infections in
cirrhosis, map infection pathogens, correlate the characteristics of the underlying immune
status with the pathogen profiles of secondary infections, and set up an early warning system
of secondary infection surveillance, with the aim of early prevention and early recognition
of secondary infections, and improvement of prognosis for patients with liver cirrhosis.