Predictors of Decompensation, Acute-on-chronic Liver Failure and Mortality in Liver Cirrhosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observation.
- Who it may be relevant to
- Registry conditions: Cirrhosis and Chronic Liver Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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)
Overview
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
Interventions
- Other Observation
Patients with liver cirrhosis will be observed to monitor for death
Primary outcome measures
- All cause mortality [Time frame: Up to 10 years from date of enrollment]
Secondary outcome measures (1)
- Decompensation of liver cirrhosis [Time frame: 10 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Singapore · 3 centers
- Changi General Hospital — Singapore
- Sengkang General Hospital — Singapore
- Singapore General Hospital — Singapore
Publications
- 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, PMID 32673741
Identifiers
NCT: NCT07438288 · 2022-2039