Natural Course and Prognosis of Hospitalized Patients With Cirrhosis

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

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

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 336

Contacts and Locations

• Study Contact: Name: Won Sohn, MD, PhD; Phone Number: 82-2-2001-2557; Email: hand0827@naver.com

Study Locations

• Korea, Republic of
  • Hwaseong-si, Korea, Republic of
    • Recruiting
    • Hallym University Dongtan Sacred Heart Hospital
    • Contact: Jung Hee Kim, MD, MSc; Phone Number: 82-31-8086-2460; Email: mazyyang5@gmail.com
  • Kwangju, Korea, Republic of
    • Recruiting
    • Chosun University Hospital
    • Contact: Ju-Yeon Cho, MD, PhD; Phone Number: 82-62-230-3016; Email: intelheal@gmail.com
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Kangbuk Samsung Hospital
    • Contact: Won Sohn, MD, PhD; Phone Number: 82-2-2001-2557; Email: hand0827@naver.com
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Jae Yoon Jeong
    • Contact: Jae Yoon Jeong, MD, PhD; Phone Number: 82-2-2276-2316; Email: jyjeong@nmc.or.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Hospitalized patients with liver cirrhosis

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Death from any cause	Up to 2 years
Liver-related mortality	Death from liver disease	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cause of admission to hospital	Prevalence of cause of admission to hospital	At baseline

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital
• Investigators: Principal Investigator: Won Sohn, MD, PhD, Kangbuk Samsung Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): October 31, 2025

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: KBSMCLC2021

Drug and device information, study documents

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