Characteristics and Risk Factors for Invasive Fungal Infection With Acute-on-chronic Hepatitis B Liver Failure

January 2, 2024 updated by: Qilu Hospital of Shandong University

Characteristics and Risk Factors for Invasive Fungal Infection in Hospitalized Patients With Acute-on-chronic Hepatitis B Liver Failure: A Retrospective Cohort Study From 2010 to 2023

This is a single-center retrospective study. The clinical data of patients with Acute-on-chronic Hepatitis B liver failure who were hospitalized in the Department of Hepatology, Qilu Hospital of Shandong University from January 2010 to July 2023 were collected.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The clinical data of patients with Acute-on-chronic Hepatitis B liver failure who were hospitalized in the Department of Hepatology, Qilu Hospital of Shandong University from January 2010 to July 2023 were collected, including age, gender, HBsAg,HBeAg, serum hepatitis B virus DNA, alanine aminotransferase, aspartate aminotransferase, Platelet, white blood cell,neutrophilic granulocyte percentage, neutrophile granulocyte, total bilirubin, creatinine, international normalized ratio,procalcitonin,globulin. prothrombin time activity, 1, 3 - beta glucan D test, Galactomannan test, sputum culture, imaging CT and other indicators. Our study followed up patients with Acute-on-chronic Hepatitis B liver failure with fungal infection during hospitalization to clarify the clinical characteristics and risk factors of fungal infection in the development of Acute-on-chronic Hepatitis B liver failure , and to provide clinical prevention and treatment recommendations for fungal infection in patients with Acute-on-chronic Hepatitis B liver failure . Thus, the prognosis of patients can be improved and the survival rate can be increased.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The clinical data of patients with Acute-on-chronic hepatitis B liver failure hospitalized in the Department of Hepatology, Qilu Hospital of Shandong University from January 2010 to July 2023 were retrospectively collected. According to the inclusion criteria, 244 patients were finally included.

Description

Inclusion Criteria:

  • Acute liver function injury TBIL≥5mg/dl(85umol/L) and international normalized ratio (INR) ≥1.5 or PTA≤40% based on previously known chronic hepatitis B or compensated cirrhosis.
  • Combined with ascites and/or hepatic encephalopathy within 4 weeks.
  • HBsAg（+)>6 months

Exclusion Criteria:

  • Patients died within 48 hours of admission or withdrew treatment.
  • Combined with liver cancer and other extrahepatic organ malignant tumors, rheumatic diseases, hyperthyroidism.
  • Age <18 years old.

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

Cohorts and Interventions

Group / Cohort
invasive fungal infection group and non-invasive fungal infection group
According to the presence or absence of invasive fungal infection, the patients were divided into invasive fungal infection group and non-invasive fungal infection group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with invasive fungal infection
Time Frame: January 2010 to July 2023
Invasive candidiasis: isolation of Candida in one or more blood cultures (candidemia) or from normal sterile body fluids. Candida colonization: Candida was isolated in non-sterile fluid without infection. Probable invasive aspergillosis: Detection of Aspergillus by direct examination and/or culture of respiratory specimens under imaging that is consistent with the presence of pulmonary infection. Probable invasive fungal infection(IFI) was defined as the presence of clinical features including lower respiratory tract mycosis (nodules, halo sign, air crescent sign, or cavity on chest CT scan) and a positive aspergillus culture in sputum specimen. In fact, the definitions of probable IFI and IFI are the same, except that probable IFI lacks mycological evidence.
January 2010 to July 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Investigators

  • Study Chair: Yu-Chen Fan, MD,PhD, QiLU Hospital of ShanDong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

January 20, 2024

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

December 17, 2023

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-202310-035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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