Study on Prognosis of Acute-on-chronic Liver Failure Complicated by Bacterial or Fungal Infection

Acute-On-Chronic Liver Failure Clinical Trial

Official title:

A Real-world Study on the Long-term Prognosis of Acute-on-chronic Liver Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06437067
• Other study ID #: ACLF-I
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Tongji Hospital
• Contact: Tao Chen, Professor
• Phone: +8618971419301
• Email: chentao_tjh[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The subjects of this study were inpatients with ACLF who were admitted to Tongji Hospital in Wuhan from March 2023 to June 2025. After patients were enrolled, The patient's general information (gender, age, past medical history, etc.), complications (ascites, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding, etc.), laboratory tests (CRP, PCT, INR, WBC, fungal/bacterial diagnostic tests, etc.), symptoms and signs at the time of infection, and at admission (D1), D4, D7, D14, D21, etc.) were recorded Save the blood separately. The patients were divided into fungal infection group, bacterial infection group and non-infection group according to the infection status after admission.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. TBIL = 12 mg/mL and INR = 1.5

2. Chronic hepatitis B

Exclusion Criteria:

(1) <18 or >80 years old; (2) primary hepatic or extrahepatic carcinoma; (3) with severe diseases of other organs or systems; (4) pregnancy; (5) imcomplete information

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatic Insufficiency
• Liver Failure

Locations

Country	Name	City	State
China	Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Qin Ning

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence rate of bacterial or fungal infection	incidence rate of bacterial or fungal infection	28 days and 90 days
Primary	mortality rate of bacterial or fungal infection	mortality rate of bacterial or fungal infection	28 days and 90 days
Secondary	incidence rate of complications	incidence rate of complications	28 days and 90 days