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

NCT ID: NCT06190002

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-20
• Study Completion Date: 2024-05-31

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.

Conditions

Acute-on-chronic Hepatitis B Liver Failure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

No interventions assigned to this group

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Chen Fan, MD,PhD

Role: STUDY_CHAIR

Qilu Hospital of Shandong University

Central Contacts

Yu-Chen Fan, MD,PhD

Role: CONTACT

fanyuchen@sdu.edu.cn

18560082065

References

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.

Reference Type: BACKGROUND

PMID: 18462102 (View on PubMed)

Other Identifiers

KYLL-202310-035

Identifier Type: -

Identifier Source: org_study_id