NCT07438288

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

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,200 (estimated)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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

Conditions

• Cirrhosis and Chronic Liver Disease

Interventions

Type	Name	Description
OTHER	Observation	Patients with liver cirrhosis will be observed to monitor for death

Timeline

• Start date: 2022-08-12
• Primary completion: 2027-08-12
• Completion: 2032-08-12
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

3 sites across 1 country: Singapore