Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06272071
Other study ID # 2023YFC2308802-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2024
Est. completion date November 2026

Study information

Verified date March 2024
Source Zhejiang University
Contact Jiajia Chen
Phone +8615967109232
Email Jiajiatale0@zju.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Liver failure is a clinical syndrome caused by a large number of necrotic hepatocytes leading to severe liver function damage, with jaundice, coagulation dysfunction and hepatic encephalopathy as the main manifestations, which can be caused by a variety of reasons, and the liver failure caused by Hepatitis B Virus (HBV) is the first one in our country, which accounts for about 80% of the cases. Through the "Eleventh Five-Year Plan" to "Thirteenth Five-Year Plan" national scientific and technological major special projects, the death rate of patients with early and middle stage of severe hepatitis B has been significantly reduced, but the death rate of patients with advanced stage is still as high as about 60%, especially when liver failure is combined with other complications, such as This study focuses on the impact of secondary infections on the clinical prognosis of severe hepatitis (liver failure), and intends to establish a prospective, multi-center clinical cohort of secondary infections in liver failure, map the infectious pathogens, correlate the basic immune status with the characteristics of the pathogen profile of the secondary infections, and establish a monitoring and early-warning system of secondary infections, so as to explore safe and effective treatment modalities. To further reduce the mortality rate of liver failure.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 2000
Est. completion date November 2026
Est. primary completion date November 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Patients agreed to participate in the study and signed an informed consent form; 2. Sex is not limited and age is 18-70 years old; 3. HBsAg positive for more than 6 months, or hepatitis E IgM positive, or hepatitis E RNA positive; 4. 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); 5. Sgnificant bleeding tendency with PTA = 40% and exclusion of other non-hepatic factors. Exclusion Criteria: 1. Patients with severe hepatitis caused by other non-hepatophilic viral infections; 2. Patients who were considered by the investigator to be unsuitable for participation in the study.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
Zhejiang University Beijing Ditan Hospital, Beijing YouAn Hospital, Huashan Hospital, Qilu Hospital of Shandong University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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. 8 weeks
Secondary 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. 12 weeks
Secondary 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. 8 weeks
Secondary 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. 12 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT03791190 - RCA for CRRT in Liver Failure and High Risk Bleeding Patients N/A
Recruiting NCT05989958 - The Safety and Tolerability Study of HepaCure in Chinese Subjects With Acute-On-Chronic Liver Failure Phase 1
Completed NCT02557724 - Mobilization of Mesenchymal Stem Cells During Liver Transplantation
Recruiting NCT01698723 - A Trial of Ribavirin in Patients With ACLF Due to Hepatitis E Virus Phase 2
Completed NCT01404793 - SPME For Metabolomics And Concomitant Measurements Of Rocuronium Bromide Levels In Liver Transplantation N/A
Completed NCT01425385 - Autoregulation Assessment During Liver Transplantation N/A
Completed NCT00808691 - Microcirculation and Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit N/A
Completed NCT03864497 - Myocardial Perfusion Imaging in Liver Transplantation Candidates
Completed NCT00287235 - Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS) N/A
Completed NCT03650920 - Hepatitis C Virus (HCV) Positive Liver Grafts in HCV Negative Recipients N/A
Recruiting NCT05517668 - Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose Phase 2
Recruiting NCT05726032 - Empagliflozin in Patients With Cirrhosis and Ascites Phase 2
Recruiting NCT04548596 - NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
Recruiting NCT02331745 - RCT Study on Granulocyte Colony-stimulating Factor(G-CSF) Treatment of Hepatic Failure Phase 4
Not yet recruiting NCT01961440 - Prognosis Scoring System for Acute-on-Chronic Liver Failure N/A
Active, not recruiting NCT01221454 - Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure Phase 2
Completed NCT00772148 - Pharmacokinetics of LCP-Tacroâ„¢ Once Daily and Prograf® Twice A Day in Adult De Novo Liver Transplant Patients Phase 2
Completed NCT05592106 - Gd-EOB-DTPA-enhanced T1 Map for Predicting Postoperative Liver Failure
Not yet recruiting NCT06014320 - Alterations in Coagulation Factor Levels in Patients With End Stage Liver Disease
Recruiting NCT04221672 - The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy Phase 3