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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Cirrhosis

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Jiajia Chen; Phone Number: +8615967109232; Email: Jiajiatale0@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatic virus-caused cirrhosis

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate	12-week survival in infected patients with viral hepatitis cirrhosis	12 weeks

Collaborators and Investigators

• Sponsor: Zhejiang University
• Collaborators: Beijing YouAn Hospital; Beijing Ditan Hospital; Huashan Hospital; Qilu Hospital of Shandong University
• Investigators: Principal Investigator: Jiajia Chen, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 18, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Infection; Cohort study; Pathogen spectrum; Hepatic virus-caused cirrhosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Infections; Liver Cirrhosis
• Other Study ID Numbers: 2023YFC2308802-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No