A Clinical Cohort Study on the Pathogen Spectrum of Hepatic Virus-caused Cirrhosis Complicated With Infection

Liver Cirrhosis Clinical Trial

Official title:

A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of Hepatic Virus-caused Cirrhosis Complicated With Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06279845
• Other study ID #: 2023YFC2308802-02
• Status: Not yet recruiting
• 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
• 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Hospitalized patients with viral hepatitis cirrhosis agreed to participate in the study and signed an informed consent form;

2. Any gender and age between 18-70 years old;

3. HBsAg positivity lasting more than 6 months;

4. have clinical manifestations of hepatic decompensation and portal hypertension, laboratory test results, liver imaging or endoscopy and other comprehensive diagnosis of definite cirrhosis.

Exclusion Criteria:

1. Patients with other non-hepatophilic causes of cirrhosis;

2. Patients who, in the opinion of the investigator, are not suitable for participation in the study.

Related Conditions & MeSH terms

• Fibrosis
• Infections
• Liver Cirrhosis

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Zhejiang University	Beijing Ditan Hospital, Beijing YouAn Hospital, Huashan Hospital, Qilu Hospital of Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Secondary infection in patients at 4 weeks	Site of infection, pathogen results such as blood or body fluid pathogen cultures or Next-generation sequencing(NGS) results.	4 weeks
Primary	quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks	qSOFA consists of 3 items: altered state of consciousness, systolic blood pressure = 100 mmHg, and respiratory rate = 22 respirations/min. 2 or more items, i.e., a qSOFA score of = 2, are considered to be suspicious for sepsis.Higher qSOFA scores are associated with a higher risk of patient death.	4 weeks
Secondary	Survival rate	12-week survival in infected patients with viral hepatitis cirrhosis	12 weeks