NCT05393453

Brief Summary

Patients with Acute on Chronic Liver Failure (ACLF) have high short-term mortality. The use of a severity score could define the patient's prognosis. This study mainly prospectively analyze the clinical data of patients with chronic liver disease related acute liver failure admitted to the department of infectious diseases, Xiangya Hospital of Central South University, to analyze the prognosis of patients with chronic liver disease related acute on-chronic liver failure in Central South China. No additional interventions other than routine treatment will be added.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 14, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 16, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

May 14, 2022

Last Update Submit

June 14, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • Non-liver transplant mortality

    short time mortality

    15 days

  • Non-liver transplant mortality

    short time mortality

    30 days

  • Non-liver transplant mortality

    short time mortality

    90 days

  • Non-liver transplant mortality

    long time mortality

    12 months

  • Non-liver transplant mortality

    long time mortality

    36 months

Secondary Outcomes (6)

  • Liver transplantation rate

    1 month

  • Liver transplantation rate

    6 months

  • Liver transplantation rate

    12 months

  • Model for disease severity

    1 month

  • Model for disease severity

    6 months

  • +1 more secondary outcomes

Study Arms (1)

patients with acute on chronic liver failure

All subjects will receive the currently routine treatment of liver failure and corresponding etiological treatment if needed. The researchers will collect various clinical examination results of the subjects in the process of diagnosis and treatment, including but not limited to blood routine, biochemistry, coagulation function, liver imaging, therapeutic drugs, etc. Complications and prognosis of patients will be recorded. Blood samples, urine and stool samples of all subjects will be collected after enrollment and stored for probably testing in the future. This study has no additional intervention and treatment for subjects.

Eligibility Criteria

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

Patient with any cause of chronic liver disease who underwent acute liver dysfunction meets the criteria of ACLF of APASL.

You may qualify if:

  • patients with evidence of chronic liver disease patients with liver failure

You may not qualify if:

  • Patients who do not have chronic liver disease Patients who have hepatocellular carcinoma Patients who admitted for extrahepatic manifestations Patients who have HIV infection Patients who admitted for symptomatic control of chronic liver disease, other than acute deterioration of liver function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital

Changsha, Hunan, 410000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood includes blood cells and serum, urine and fecal samples

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, AcuteLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Central Study Contacts

Yan Huang, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2022

First Posted

May 26, 2022

Study Start

June 1, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2025

Last Updated

June 16, 2022

Record last verified: 2022-05

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