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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
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.
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.
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.
Locations
Sponsors and contacts
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Zhejiang University
Lead sponsor
Beijing Ditan Hospital
Collaborator
Beijing YouAn Hospital
Collaborator
Huashan Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
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