Prognosis of Patients With Acute-on-chronic Liver Failure

The Investigate Outcomes and Prognostic Factors of Patients With Acute-on-chronic Liver Failure

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.

Study Overview

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

Detailed Description

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 and would help determine in whom the treatment is effective. 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 short-time and relatively long-term prognosis of patients with chronic liver disease related acute on-chronic liver failure. This is an observational study. All subjects will receive the currently recognized routine treatment of liver failure and corresponding etiological treatment if needed. The researchers will collect various clinical examination indexes 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 taken after enrollment and stored for probably testing in the future. This study has no additional intervention and treatment for subjects. All subjects will sign informed consent.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Yan Huang, Professor; Phone Number: 13874854142; Email: drhyan@163.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • Xiangya Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver transplantation rate	mortality of all patients including those receiving liver transplantation	1 month
Liver transplantation rate	mortality of all patients including those receiving liver transplantation	6 months
Liver transplantation rate	mortality of all patients including those receiving liver transplantation	12 months
Model for disease severity	MELD score will be calculated and reported	1 month
Model for disease severity	MELD score will be calculated and reported	6 months
Model for disease severity	MELD score will be calculated and reported	12 months

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: May 14, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: May 1, 2022

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: Xiangya ACLF project

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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