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

NCT07438288 | Recruiting

• 1 other identifier: 2022-2039
• Study Type: observational
• Target: 2,200
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cirrhosis and Chronic Liver Disease

Keywords

Cirrhosis; Decompensation; Acute-on-chronic liver failure; Death

Outcome Measures

Primary Outcomes (1)

• All cause mortality

  Death from any cause will be recorded during the study period

  Up to 10 years from date of enrollment

Secondary Outcomes (1)

• Decompensation of liver cirrhosis

  10 years

Study Arms (1)

Patients with liver cirrhosis

Other: Observation

Interventions

Observation OTHER

Patients with liver cirrhosis will be observed to monitor for death

Patients with liver cirrhosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (3)

Changi General Hospital

Singapore, Singapore

RECRUITING

Sengkang General Hospital

Singapore, Singapore

RECRUITING

Singapore General Hospital

Singapore, Singapore

RECRUITING

Related Publications (1)

• Trebicka J, Fernandez J, Papp M, Caraceni P, Laleman W, Gambino C, Giovo I, Uschner FE, Jimenez C, Mookerjee R, Gustot T, Albillos A, Banares R, Janicko M, Steib C, Reiberger T, Acevedo J, Gatti P, Bernal W, Zeuzem S, Zipprich A, Piano S, Berg T, Bruns T, Bendtsen F, Coenraad M, Merli M, Stauber R, Zoller H, Ramos JP, Sole C, Soriano G, de Gottardi A, Gronbaek H, Saliba F, Trautwein C, Ozdogan OC, Francque S, Ryder S, Nahon P, Romero-Gomez M, Van Vlierberghe H, Francoz C, Manns M, Garcia E, Tufoni M, Amoros A, Pavesi M, Sanchez C, Curto A, Pitarch C, Putignano A, Moreno E, Shawcross D, Aguilar F, Claria J, Ponzo P, Jansen C, Vitalis Z, Zaccherini G, Balogh B, Vargas V, Montagnese S, Alessandria C, Bernardi M, Gines P, Jalan R, Moreau R, Angeli P, Arroyo V; PREDICT STUDY group of the EASL-CLIF Consortium. The PREDICT study uncovers three clinical courses of acutely decompensated cirrhosis that have distinct pathophysiology. J Hepatol. 2020 Oct;73(4):842-854. doi: 10.1016/j.jhep.2020.06.013. Epub 2020 Jul 13.

  PMID: 32673741 BACKGROUND

MeSH Terms

Conditions

Fibrosis; Acute-On-Chronic Liver Failure; Death

Interventions

Observation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Jason Pik Eu Chang, MBBS, MRCP

CONTACT

+65 6321 4684; jason.chang@singhealth.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: February 27, 2026
• Study Start: August 12, 2022
• Primary Completion (Estimated): August 12, 2027
• Study Completion (Estimated): August 12, 2032
• Last Updated: February 27, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Aug 2022 to Aug 2027
• Access Criteria: Potential research collaborators (e.g. to publish meta-analysis or external validation studies)

Locations

SG (3)