Prognosis of Patients With Acute-on-chronic Liver Failure

Acute-On-Chronic Liver Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05393453
• Other study ID #: Xiangya ACLF project
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2022
• Source: Xiangya Hospital of Central South University
• Contact: Yan Huang, Professor
• Phone: 13874854142
• Email: drhyan[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Xiangya Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-liver transplant mortality	short time mortality	15 days
Primary	Non-liver transplant mortality	short time mortality	30 days
Primary	Non-liver transplant mortality	short time mortality	90 days
Primary	Non-liver transplant mortality	long time mortality	12 months
Primary	Non-liver transplant mortality	long time mortality	36 months
Secondary	Liver transplantation rate	mortality of all patients including those receiving liver transplantation	1 month
Secondary	Liver transplantation rate	mortality of all patients including those receiving liver transplantation	6 months
Secondary	Liver transplantation rate	mortality of all patients including those receiving liver transplantation	12 months
Secondary	Model for disease severity	MELD score will be calculated and reported	1 month
Secondary	Model for disease severity	MELD score will be calculated and reported	6 months
Secondary	Model for disease severity	MELD score will be calculated and reported	12 months