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

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.

Recruiting

Interested in participating?

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Key information

Conditions

Cirrhosis and Chronic Liver Disease Acute-On-Chronic Liver Failure Death Digestive System Diseases Fibrosis Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Changi General Hospital, Singapore

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

observation

Other

Patients with liver cirrhosis will be observed to monitor for death

Primary outcomes

All cause mortality

Time frame: Up to 10 years from date of enrollment

Death from any cause will be recorded during the study period

Secondary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jason Pik Eu Chang, MBBS, MRCP

CONTACT

[email protected]

+65 6321 4684

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Registry information

Official study title

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)

Acronym: SoLiDaRity

Important dates

Study start: 2022
Primary completion: 2027
Study completion: 2032
First posted: Feb 27, 2026
Registry last updated: Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed