About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
No clinical evidence of liver cirrhosis
Not willing to provide informed consent
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Observation
Other interventionPatients with liver cirrhosis will be observed to monitor for death
Treatment groups
Trial outcomes
Primary outcomes
All cause mortality
Death from any cause will be recorded during the study period
Secondary outcomes
Decompensation of liver cirrhosis
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.
Sponsors and contacts
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