An observational study in Cirrhosis and Decompensated Cirrhosis of Liver, sponsored by Samsung Medical Center. Active, not recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by Samsung Medical Center · Observational
The goal of this observational study is to learn if non-selective beta-blockers (NSBB) improve outcomes in patients with chronic hepatitis B or C who are discharged after hospitalization for acute decompensation of cirrhosis. The main questions it aims to answer are:
Researchers will compare patients discharged with NSBB prescriptions to those without NSBB to see if NSBB use decreases mortality and readmission rates.
Participants were patients hospitalized for hepatic complications (hepatic encephalopathy, hepatorenal syndrome, ascites, or spontaneous peritonitis) between January 2013 and October 2023, with data analyzed retrospectively using a target trial emulation design.
This retrospective cohort study aims to investigate the effects of non-selective beta-blockers (NSBB) on clinical outcomes in patients with chronic hepatitis B or C who were hospitalized for acute decompensation of cirrhosis. The study employs a target trial emulation design to simulate a randomized controlled trial using observational data.
Background and Rationale:
Non-selective beta-blockers are commonly used in patients with cirrhosis to reduce portal pressure and prevent complications. However, their role in patients discharged after hospitalization for hepatic complications remains unclear.
Study Design:
The study uses national health insurance claims data from South Korea to identify eligible patients and their outcomes. To address potential confounding inherent in observational studies, three analytical approaches are employed:
Treatment Definition:
NSBB use is defined as a prescription for at least 2 days at discharge. Two types of NSBB are examined: propranolol and carvedilol. Dosage effects are also explored by categorizing NSBB use into low-dose and middle-high dose groups.
Endpoints:
The primary endpoint is all-cause mortality, while secondary endpoints include all-cause hospital readmission and hepatic complication-related hospital readmission. All endpoints are assessed at 1 month, 3 months, 6 months, and 1 year after discharge.
Statistical Analysis:
Kaplan-Meier survival analyses and Cox proportional hazards models will be used to compare outcomes between treatment groups. Models will be adjusted for demographic factors, comorbidities, concurrent medications, health behaviors, and admission-related variables. Subgroup analyses will be conducted based on age, sex, and type of hepatic complication.
This study aims to provide clinicians with evidence regarding the use of NSBB in patients with viral hepatitis-related cirrhosis following hospitalization for acute decompensation, potentially informing clinical decision-making for this high-risk population.
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The study will include adult patients with liver cirrhosis and chronic hepatitis B or C who were hospitalized due to hepatic complications in South Korea between January 2013 and October 2023. The study will focus on patients who experienced hepatic complications including ascites, peritonitis, hepatorenal syndrome, and hepatic encephalopathy. Both patients who received NSBB at discharge and those who did not will be included in the analysis to allow for comparison between these groups.
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Exclusion Criteria:
Patients with chronic hepatitis B or C who were hospitalized for hepatic complications (hepatic encephalopathy, hepatorenal syndrome, ascites, or spontaneous peritonitis) and received NSBB prescription at discharge. The study will compare outcomes in this group with the non-NSBB group.
Drug: Non-selective beta-blockers
Patients with chronic hepatitis B or C who were hospitalized for hepatic complications (hepatic encephalopathy, hepatorenal syndrome, ascites, or spontaneous peritonitis) and did not receive NSBB prescription at discharge. This group will serve as the control group for comparison.
Non-selective beta-blockers (NSBB) prescribed at discharge for patients hospitalized with hepatic complications. The study will analyze two types of NSBB: propranolol and carvedilol. The study will also examine potential dosage effects by categorizing NSBB use into low-dose and middle-high dose groups. NSBB use is defined as a prescription for at least 2 days at discharge.
Also known as: Carvedilol, Propranolol
All-cause mortality
Death from any cause following discharge after hospitalization for hepatic complications of cirrhosis. Mortality data will be obtained through death registry linkage. Hazard ratios (HR) will be calculated using Cox proportional hazards models, adjusted for demographic factors, comorbidities, medications at discharge, health behaviors, and admission-related variables.
Time frame: 1 month, 3 months, 6 months, and 1 year after discharge from index hospitalization
All-cause hospital readmission
Any hospital readmission following discharge after the index hospitalization for hepatic complications of cirrhosis. Readmission data will be obtained from hospitalization claims. Hazard ratios (HR) will be calculated using Cox proportional hazards models, adjusted for demographic factors, comorbidities, medications at discharge, health behaviors, and admission-related variables.
Time frame: 1 month, 3 months, 6 months, and 1 year after discharge from index hospitalization
Hepatic complication-related hospital readmission
Hospital readmission specifically related to hepatic complications (hepatic encephalopathy, hepatorenal syndrome, ascites, or spontaneous peritonitis) following discharge after the index hospitalization. Readmission data will be categorized based on diagnosis codes in hospitalization claims. The same statistical methods as for all-cause readmission will be applied.
Time frame: 1 month, 3 months, 6 months, and 1 year after discharge from index hospitalization
Plan to share: No — Individual participant data will not be shared due to the sensitive nature of the medical information and patient privacy concerns.
Ran from Jan 2013 to primary completion in Oct 2023, 129 months.
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This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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