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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSingapore General Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observation

    Other intervention

    Patients with liver cirrhosis will be observed to monitor for death

Treatment groups

2,200 Participants
are divided into 1 treatment group
Group A: Patients with liver cirrhosis1 intervention

Trial outcomes

Primary outcomes

1

All cause mortality

Death from any cause will be recorded during the study period

Time frame
Up to 10 years from date of enrollment

Secondary outcomes

1

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.

Time frame
10 years

Other outcomes

Sponsors and contacts

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