Clinical trial NCT06190002: Characteristics and Risk Factors for Invasive Fungal Infection With Acute-on-chronic Hepatitis B Liver Failure
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute-on-chronic Hepatitis B Liver Failure
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with invasive fungal infection
timeFrame: January 2010 to July 2023
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yu-Chen Fan, MD,PhD
role: STUDY_CHAIR
References:
citation: De Pauw B, Walsh TJ, Donnelly JP, Stevens DA, Edwards JE, Calandra T, Pappas PG, Maertens J, Lortholary O, Kauffman CA, Denning DW, Patterson TF, Maschmeyer G, Bille J, Dismukes WE, Herbrecht R, Hope WW, Kibbler CC, Kullberg BJ, Marr KA, Munoz P, Odds FC, Perfect JR, Restrepo A, Ruhnke M, Segal BH, Sobel JD, Sorrell TC, Viscoli C, Wingard JR, Zaoutis T, Bennett JE; European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group; National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Clin Infect Dis. 2008 Jun 15;46(12):1813-21. doi: 10.1086/588660.