Predictors of Decompensation, Acute-on-chronic Liver Failure and Mortality in Liver Cirrhosis (SoLiDaRity)

February 22, 2026 updated by: Singapore General Hospital

Predictors of Decompensation, Acute-on-chronic Liver Failure and Mortality in Liver Cirrhosis - a Multicentre, Prospective, Observational Study From the SingHealth Chronic Liver Disease Registry (SoLiDaRity-DAM)

The purpose of this study is to identify factors that predict the development of decompensation, acute-on-chronic liver failure (ACLF) and death in patients with liver cirrhosis. Clinical data will be retrieved from existing hospital records. This information may help doctors to identify patients with cirrhosis who are at risk of deterioration earlier (before they develop complications) and to develop effective treatment strategies to prevent or delay these complications.

This study is designed as a prospective, non-interventional, observational study. This means that if you agree to participate in the study, you will not be required to undergo any additional hospital visits, tests, procedures or interventions other than the usual standard-of-care management that your doctor will provide. If you consent to participate in this study, you will be providing the study investigators permission to review and analyse your clinical data from the hospital clinical records. Your data will be collected throughout the course of your disease until liver transplantation or death.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary aim of this study is to prospectively identify factors that predict decompensation, ACLF and death in patients with cirrhosis.

Specific goals of the study:

  • To study the 1-, 3- and 5-year risk of decompensation, ACLF and death in patients with compensated and decompensated liver cirrhosis in Singapore
  • To identify clinically relevant point-in-time predictors and biomarkers for liver decompensation in general, and for specific liver-related events (including variceal bleeding, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, portal vein thrombosis, portopulmonary hypertension, hepatopulmonary syndrome, cirrhotic cardiomyopathy, hepatorenal syndrome, refractory ascites, sarcopenia, and liver cancer)
  • To study the impact of underlying etiology of liver disease on the rate of decompensation, ACLF and death in liver cirrhosis
  • To provide external validation of predictive scores for decompensation (ALBI, CHESS-ALARM, LSPS, PREDICT, etc).
  • To serve as a core (hub) study for prospective ancillary studies regarding diagnosis, prognosis, and pathogenesis of AD and ACLF

Study Type

Observational

Enrollment (Estimated)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore
        • Recruiting
        • Singapore General Hospital
        • Contact:
        • Principal Investigator:
          • Chang Jason
      • Singapore, Singapore
        • Recruiting
        • Changi General Hospital
        • Contact:
        • Principal Investigator:
          • Rahul Kumar
      • Singapore, Singapore
        • Recruiting
        • Sengkang General Hospital
        • Contact:
        • Principal Investigator:
          • Marianne Anastasia De Roza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This multicenter study aims to recruit 2,200 cirrhotic patients over a 5 year period from 3 institutions in SingHealth - Changi General Hospital (CGH), Sengkang General Hospital (SKH) and Singapore General Hospital (SGH).

Patients will be recruited both from the inpatient and outpatient setting. All consecutive patients admitted/referred to the study center with a clinical diagnosis of liver cirrhosis (based on standard clinical, radiological, elastography and/or histological criteria) will be offered inclusion into the SoLiDaRity-DAM study.

Description

Inclusion Criteria:

  1. Patients with clinical diagnosis of liver cirrhosis
  2. Age 18 years and above (parental consent required if below 21 years)
  3. Willing and able to provide informed consent

Exclusion Criteria:

  • No clinical evidence of liver cirrhosis
  • Not willing to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with liver cirrhosis
Other: Observation
Patients with liver cirrhosis will be observed to monitor for death

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: Up to 10 years from date of enrollment
Death from any cause will be recorded during the study period
Up to 10 years from date of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decompensation of liver cirrhosis
Time Frame: 10 years
Occurence of first episode of hepatic decompensation, defined as the development of any of the following clinical events: variceal bleeding, hepatic encephalopathy, ascites, hepatocellular carcinoma, portal vein thrombosis, sepsis and acute-on-chronic liver failure (ACLF). Diagnosis will be based on standard clinical, laboratory or imaging criteria. These data will be retrieved from hospital clinical records.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2022

Primary Completion (Estimated)

August 12, 2027

Study Completion (Estimated)

August 12, 2032

Study Registration Dates

First Submitted

September 17, 2025

First Submitted That Met QC Criteria

February 22, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 22, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-2039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data on baseline clinical characteristics and liver related outcomes

IPD Sharing Time Frame

Aug 2022 to Aug 2027

IPD Sharing Access Criteria

Potential research collaborators (e.g. to publish meta-analysis or external validation studies)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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