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NCT05185154 Clinical Trial

Natural Course and Prognosis of Hospitalized Patients With Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:
Natural Course and Prognosis of Hospitalized Patients With Cirrhosis: a Prospective, Multicenter, and Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05185154
Other study ID # KBSMCLC2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date October 31, 2025

Study information
Verified date January 2022
Source Kangbuk Samsung Hospital
Contact Won Sohn, MD, PhD
Phone 82-2-2001-2557
Email hand0827@naver.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this prospective study is to evaluate the natural course and prognosis of hospitalized patients with liver cirrhosis.

Description:

The aim of this prospective study is to collect data on hospitalized patients with liver cirrhosis at four institutions in Korea (Kangbuk Samsung Hospital, Hallym University Dongtan Sacred Heart Hospital, Chosun University Hospital, and National Medical Center). If patients agree to participate in this clinical trial, the patients' data (such as age, sex, height, weight, nutrition status [RFH-NPT], history of medication, laboratory findings, endoscopic findings, and radiologic findings) will be collected in a research database. The research database will be updated, every 6 months, to include data on patients' disease outcomes and follow-up care.

Recruitment information / eligibility
Status Recruiting
Enrollment 336
Est. completion date October 31, 2025
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Hospitalized patients with liver cirrhosis - Admission to the hospital because of cirrhotic complications such as uncontrolled ascites, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, spontaneous bacterial peritonitis, hepatocellular carcinoma, acute kidney injury, bacterial infection, acute liver failure, and etc. Exclusion Criteria: - Admission to the hospital without cirrhotic complications - Patients who refuse the follow-up of outpatient department

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Hallym University Dongtan Sacred Heart Hospital Hwaseong-si
Korea, Republic of Chosun University Hospital Kwangju
Korea, Republic of Jae Yoon Jeong Seoul
Korea, Republic of Kangbuk Samsung Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary All-cause mortality Death from any cause Up to 2 years
Primary Liver-related mortality Death from liver disease Up to 2 years
Secondary Cause of admission to hospital Prevalence of cause of admission to hospital At baseline
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