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

ConditionLiver Failure
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorZhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
4 weeks
2

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.

Time frame
4 weeks

Secondary outcomes

1

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

Site of infection, pathogen results such as blood or body fluid pathogen cultures or NGS results.

Time frame
8 weeks
2

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

Site of infection, pathogen results such as blood or body fluid pathogen cultures or NGS results.

Time frame
12 weeks
3

qSOFA score at 8 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.

Time frame
8 weeks
4

qSOFA score at 12 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.

Time frame
12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang University

Lead sponsor

Beijing Ditan Hospital

Collaborator

Beijing YouAn Hospital

Collaborator

Huashan Hospital

Collaborator

Qilu Hospital of Shandong University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: