Evaluating Novel Scoring Systems to Predict Outcomes in Acute-on-Chronic Liver Failure

NCT07734896 | Not Yet Recruiting

• 1 other identifier: Predicting Outcomes in ACLF
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute-on-Chronic Liver Failure (ACLF); Liver Cirrhosis; End Stage Liver Disease

Keywords

CLIF-C ACLF-D Score; MELD-Complication Score; MELD-Na Score; Child-Pugh Score; Prognostic Scores

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days post-hospital admission

Secondary Outcomes (2)

• In-Hospital All-Cause Mortality Rate

  From date of hospital admission up to hospital discharge, assessed up to 28 days

• Prognostic Performance of the CLIF-C ACLF-D Score for 28-Day Mortality

  Baseline (day 1 of admission) up to 28 days

Study Arms (1)

ACLF Patients

Patients aged 18 years or older diagnosed with Acute-on-Chronic Liver Failure (ACLF) according to EASL-CLIF criteria and admitted to the Intensive Care Unit of the Tropical Medicine and Gastroenterology Department at Al-Rajhi University Hospital. All patients will undergo full clinical, laboratory, and radiological evaluations at baseline, followed by calculation of novel (CLIF-C ACLF-D, MELD-complication) and conventional (Child-Pugh, MELD-Na, CLIF-C ACLF) prognostic scores to predict short-term outcomes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with hepatocellular carcinoma.
• Patients with advanced extrahepatic malignancy.
• Pregnant females.
• Patients younger than 18 years old.
• Patients with incomplete clinical or laboratory data.
• Patients or first-degree relatives refusing participation.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Liver Cirrhosis; End Stage Liver Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Tropical Medicine and Gastroenterology department

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: July 29, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07