About this trial
Acute-on-chronic liver failure (ACLF) is a serious condition where a patient with long-term liver disease suddenly experiences severe liver worsening and failure of other organ systems, such as the kidneys or lungs. ACLF is associated with a high risk of short-term death, making early and accurate prediction of patient outcomes essential for guiding medical decisions.
Conventional scoring systems, such as the Child-Pugh and Model for End-Stage Liver Disease Sodium (MELD-Na) scores, are widely used to assess liver disease severity. However, these traditional models may not fully capture the intense systemic inflammation and multiorgan failure characteristic of ACLF. Recently, novel prognostic scoring models, specifically the CLIF-C ACLF-D score and the MELD-complication score, have been developed to better predict patient outcomes by integrating markers of inflammation, organ dysfunction, and clinical complications.
This study aims to evaluate and validate the clinical usefulness of these novel scoring models compared to conventional scores in predicting in-hospital and 28-day mortality among patients admitted with ACLF.
Participants enrolled in this prospective observational study will be recruited from the Intensive Care Unit (ICU) of the Tropical Medicine and Gastroenterology Department at Al-Rajhi University Hospital. Upon admission, participants will undergo routine clinical examinations, laboratory testing, and imaging. The various risk scores will be calculated at baseline. Participants will be monitored throughout their hospital stay, and their survival status will be followed for 28 days after admission to compare the accuracy of each scoring system.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years or older.
Diagnosed with Acute-on-Chronic Liver Failure (ACLF) fulfilling the diagnostic criteria according to EASL-CLIF.
Admitted to the Intensive Care Unit (ICU) of the Tropical Medicine and Gastroenterology Department, Al-Rajhi University Hospital.
Disqualifiers
Patients with hepatocellular carcinoma.
Patients with advanced extrahepatic malignancy.
Pregnant females.
Patients younger than 18 years old.
Trial population
Patients diagnosed with Acute-on-Chronic Liver Failure (ACLF) according to the EASL-CLIF diagnostic criteria who are admitted to the Intensive Care Unit (ICU) of the Tropical Medicine and Gastroenterology Department at Al-Rajhi University Hospital.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
28-Day All-Cause Mortality Rate
Percentage of participants with Acute-on-Chronic Liver Failure (ACLF) who die from any cause within 28 days following hospital admission. Survival status will be evaluated during the hospital stay and confirmed post-discharge via clinic visits or telephone follow-up.
Secondary outcomes
In-Hospital All-Cause Mortality Rate
Percentage of participants with Acute-on-Chronic Liver Failure (ACLF) who die from any cause during their hospital stay.
Prognostic Performance of the CLIF-C ACLF-D Score for 28-Day Mortality
Predictive accuracy of the novel CLIF-C ACLF-D score measured by the Area Under the Receiver Operating Characteristic Curve (AUROC) to predict 28-day all-cause mortality.
Locations
Sponsors and contacts
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