NCT06437067

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

1.8 years

First QC Date

May 25, 2024

Last Update Submit

May 25, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • incidence rate of complications

    28 days and 90 days

Study Arms (3)

non-infection group

patients without bacterial or fungal infection

bacterial infection group

patients with bacterial infection

fungal infection group

patients with fungal infection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • TBIL ≥ 12 mg/mL and INR ≥ 1.5
  • Chronic hepatitis B

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, AcuteLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Central Study Contacts

Tao Chen, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 25, 2024

First Posted

May 31, 2024

Study Start

March 1, 2023

Primary Completion

December 31, 2024

Study Completion

June 30, 2025

Last Updated

May 31, 2024

Record last verified: 2024-05

Locations