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

Not yet recruiting

• Conditions: Acute-on-chronic Hepatitis B Liver Failure

• Registration Number: NCT06190002
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

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.

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 Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-17
• Study First Submitted QC: 2024-01-02
• Last Update Submitted: 2024-01-02
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Study Start: 2024-01-20
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with invasive fungal infection	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.