A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of Severe Hepatitis (Liver Failure) Complicated With Infection

NCT06272071 | Not Yet Recruiting

• 1 other identifier: 2023YFC2308802-01
• 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 severe hepatitis (liver failure). The main questions it aims to answer are:

• Mapping of infectious agents in patients with severe hepatitis (liver failure)
• Constructing early warning predictive models to explore how to give an individualized regimen of integrated immune function.

Conditions

Liver Failure

Keywords

Severe hepatitis; Pathogen pedigree of infection; cohort study

Outcome Measures

Primary Outcomes (2)

• Occurrence of secondary infections in patients with severe viral hepatitis (liver failure) at 4 weeks, including site of infection and pathogen of infection.

  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 (4)

• Occurrence of secondary infections in patients with severe viral hepatitis (liver failure) at 8 weeks, including site of infection and pathogen of infection.

  8 weeks

• Occurrence of secondary infections in patients with severe viral hepatitis (liver failure) at 12 weeks, including site of infection and pathogen of infection.

  12 weeks

• qSOFA score at 8 weeks

  8 weeks

• qSOFA score at 12 weeks

  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 severe viral hepatitis (liver failure) who met the inclusion and exclusion criteria and were hospitalized in the First Hospital Affiliated to Zhejiang University School of Medicine, Beijing Ditan Hospital Affiliated to Capital Medical University, Beijing You'an Hospital Affiliated to Capital Medical University, Huashan Hospital Affiliated to Fudan University, and Qilu Hospital of Shandong University.

You may qualify if:

• Patients agreed to participate in the study and signed an informed consent form;
• Sex is not limited and age is 18-70 years old;
• HBsAg positive for more than 6 months, or hepatitis E IgM positive, or hepatitis E RNA positive;
• Progressive deepening of jaundice in a short period of time (serum total bilirubin greater than 10 times the upper limit of normal or rising ≥17.1 umol/L per day);

You may not qualify if:

• Patients with severe hepatitis caused by other non-hepatophilic viral infections;
• Patients who were considered by the investigator to be unsuitable 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 Failure; Hepatitis

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

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 14, 2024
• First Posted: February 22, 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