- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03977857
Prediction Model Based on Computed Tomography Liver Volume for the Short-term Mortality in Hepatitis B Related Acute-on-Chronic
February 23, 2021 updated by: He Yingli, First Affiliated Hospital Xi'an Jiaotong University
Prediction Model Based on Computed Tomography Liver Volume for Predicting Short-term Mortality in Hepatitis B-Acute-on-Chronic Liver Failure
HBV-related acute-on-chronic liver failure (HBV-ACLF) deteriorates rapidly with a high short-term mortality.
Early identification and accurate prognostic prediction was critical to improve survival rate.
This study was sought to determine the liver volumetry as predictor for short-term mortality in HBV-ACLF and develop a simpler prognostic model based on liver morphology.
Liver volumetry were determined from CT at admission.
Univariate and multivariate logistic regression were used to identify the optimum prognostic indicators and develop prognostic model.
Additionally, receiver operating characteristic curves were analyzed to evaluate the predictive ability of the model.
Study Overview
Status
Completed
Detailed Description
HBV-ACLF deteriorates rapidly with a high short-term mortality and early identification and accurate prognostic prediction may be the key to make clinical decision and improve survival rate.
Liver volume, non-invasively reflects the balance of structural collapse with hepatic regeneration, predicting the prognosis of liver diseases.
However, there is no idea whether the liver volume is an indicator to predict the mortality of HBV-ACLF patients.
The present study evaluated the difference of liver volume between 28-day survival group and non-survivals and developed a new prognostic model based on liver volume .
This study highlighted the significance of liver morphology in predicting the outcome of HBV-ACLF for the first time.
Study Type
Observational
Enrollment (Actual)
486
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Xi'an, China
- First Affiliated Hospital Xi'an Jiaotong University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All the patients were diagnosed with hepatitis B virus-related acute-on-chronic liver failure who met with the inclusion criteria and exclusion criteria.
Two cohorts of subjects were enrolled in several liver centers.
In the modeling cohort, subjects were identified retrospectively from patients with acute exacerbation of chronic hepatitis B manifesting as hepatic encephalopathy (HE), upper gastrointestinal bleeding, ascites, acute jaundice and coagulopathy, referred from January 1, 2015 to December 31,2019.
In the validation cohort, subjects were enrolled from external liver centers for validating the model.
Description
Inclusion Criteria:
- age 18-70 years, male or female.
- Acute hepatic insult manifesting as jaundice and coagulopathy, complicated within 4 weeks by ascites, and/or encephalopathy in a patient with chronic HBV infection
- Abdominal CT examination was performed within 3 days after admission
- Biochemical examinations were available within 3 days before or after CT scan
Exclusion Criteria:
- Patients with evidence of non-B hepatitis virus: alcohol abuse leads to liver failure, autoimmune leads to liver failure, oxic or other causes that might lead to liver failure
- Past or current hepatocellular carcinoma
- Serious diseases in other organ systems
- Chronic liver failure
- There was no CT imaging data or the interval between CT scan and diagnosis of liver failure >3 days
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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28-day nonsurvival or transplantation
patients who died or underwent liver transplantation within 28 days since admission
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28-day transplantation-free survival
patients who survived without liver transplantation at 28 days since admission
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival of ACLF subjects
Time Frame: 28 days
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Overall survival in subjects with hepatitis B virus-related acute-on-chronic liver failure will be summarized and compared with control subjects through study day 28.
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28 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2019
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
June 5, 2019
First Submitted That Met QC Criteria
June 5, 2019
First Posted (Actual)
June 6, 2019
Study Record Updates
Last Update Posted (Actual)
February 25, 2021
Last Update Submitted That Met QC Criteria
February 23, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Liver Failure, Acute
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- End Stage Liver Disease
- Liver Failure
- Hepatic Insufficiency
- Acute-On-Chronic Liver Failure
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
Other Study ID Numbers
- XJTU1AF2019LSK-2019-061
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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