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

NCT06279845 | Not Yet Recruiting

• 1 other identifier: 2023YFC2308802-02
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Liver Cirrhosis

Keywords

Hepatic virus-caused cirrhosis; Infection; Pathogen spectrum; Cohort study

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Survival rate

  12 weeks

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatic virus-caused cirrhosis

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang University: lead
• Beijing Ditan Hospital: collaborator
• Beijing YouAn Hospital: collaborator
• Huashan Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

According to the characteristics of infection, take blood or body fluids from the corresponding infected site.

MeSH Terms

Conditions

Liver Cirrhosis; Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Jiajia Chen

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiajia Chen

CONTACT

+8615967109232; Jiajiatale0@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician of the First Affiliated Hospital,Zhejiang University School of Medicine

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 4, 2024

Record last verified: 2024-03