Liver CirrhosisNCT05185154
Natural Course and Prognosis of Hospitalized Patients With Cirrhosis
An observational study of Liver Cirrhosis, run by Kangbuk Samsung Hospital at 4 sites in South Korea.
Trial summary
The aim of this prospective study is to evaluate the natural course and prognosis of hospitalized patients with liver cirrhosis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 336 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 1 Nov 2021to 31 Oct 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients with liver cirrhosis
Who may be able to join
- 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.
Who cannot join
- Admission to the hospital without cirrhotic complications
- Patients who refuse the follow-up of outpatient department
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites, 4 recruiting
- Recruiting
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si
Jung Hee Kim, MD, MSc, 82-31-8086-2460, mazyyang5@gmail.com
- Recruiting
Chosun University Hospital
Kwangju
Ju-Yeon Cho, MD, PhD, 82-62-230-3016, intelheal@gmail.com
- Not yet recruiting
Jae Yoon Jeong
Seoul
Jae Yoon Jeong, MD, PhD, 82-2-2276-2316, jyjeong@nmc.or.kr
- Not yet recruiting
Kangbuk Samsung Hospital
Seoul
Won Sohn, MD, PhD, 82-2-2001-2557, hand0827@naver.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Cirrhosis
- Medical subject headings
- Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Death from any cause
Measured: Up to 2 years
Liver-related mortality
Death from liver disease
Measured: Up to 2 years
Secondary outcomes (1)
Cause of admission to hospital
Prevalence of cause of admission to hospital
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Nov 2021
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 336 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Sohn, Kangbuk Samsung Hospital
- Investigators
- Won Sohn, MD, PhD, Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185154
- Sponsor's protocol ID
- KBSMCLC2021
- Status last verified
- Jan 2022
- First submitted
- 20 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Course and Prognosis of Hospitalized Patients With Cirrhosis: a Prospective, Multicenter, and Observational Study
- ClinicalTrials.gov ID
- NCT05185154
- Acronym / sponsor ID
- KBSMCLC2021
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this prospective study is to evaluate the natural course and prognosis of hospitalized patients with 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with liver cirrhosis
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Admission to the hospital without cirrhotic complications
- Patients who refuse the follow-up of outpatient department
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: Up to 2 years
Death from any cause
Liver-related mortality
Time frame: Up to 2 years
Death from liver disease
1 secondary outcome
Cause of admission to hospital
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won Sohn, MD, PhD principal investigator
Kangbuk Samsung Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Kangbuk Samsung Hospital at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Won Sohn, MD, PhD (82-2-2001-2557, hand0827@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.