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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute-On-Chronic Liver Failure

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Tao Chen, Professor; Phone Number: +8618971419301; Email: chentao_tjh@vip.sina.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Qin Ning, PHD,MD; Phone Number: +8602783662391; Email: qning@vip.sina.com
      • Principal Investigator: Qin Ning, PHD,MD
      • Sub-Investigator: Tao Chen, PHD,MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Inpatients with ACLF admitted to Tongji Hospital in Wuhan from March 2023 to June 2025.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
non-infection group; patients without bacterial or fungal infection
bacterial infection group; patients with bacterial infection
fungal infection group; patients with fungal infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence rate of bacterial or fungal infection	incidence rate of bacterial or fungal infection	28 days and 90 days
mortality rate of bacterial or fungal infection	mortality rate of bacterial or fungal infection	28 days and 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence rate of complications	incidence rate of complications	28 days and 90 days

Collaborators and Investigators

• Sponsor: Qin Ning

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 25, 2024
• First Submitted That Met QC Criteria: May 25, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 25, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure, Acute; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure
• Other Study ID Numbers: ACLF-I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No