A 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.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Hospitalized patients with viral hepatitis cirrhosis agreed to participate in the study and signed an informed consent form;
Any gender and age between 18-70 years old;
HBsAg positivity lasting more than 6 months;
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

Patients with other non-hepatophilic causes of cirrhosis;
Patients who, in the opinion of the investigator, are not suitable for participation in the study.

Treatment and study plan

Primary outcomes

Secondary infection in patients at 4 weeks

Time frame: 4 weeks

Site of infection, pathogen results such as blood or body fluid pathogen cultures or Next-generation sequencing(NGS) results.
quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks

Time frame: 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.

Secondary outcomes

Survival rate

Time frame: 12 weeks

12-week survival in infected patients with viral hepatitis cirrhosis

Study contacts

Contact information is provided by the study sponsor or research team.

Jiajia Chen

CONTACT

[email protected]

+8615967109232

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Collaborators

Beijing Ditan Hospital
Beijing YouAn Hospital
Huashan Hospital
Qilu Hospital of Shandong University

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Feb 28, 2024
Registry last updated: Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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