An observational study in Acute-on-Chronic Liver Failure (ACLF), Liver Cirrhosis and End Stage Liver Disease, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Assiut University · Observational
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.
Acute decompensation in liver cirrhosis is the primary cause of hospitalization among cirrhotic patients. Acute-on-chronic liver failure (ACLF) represents a distinct, severe clinical entity characterized by systemic inflammation, single- or multiple-organ failures, and high short-term mortality. While traditional scoring systems like the Child-Pugh and Model for End-Stage Liver Disease Sodium (MELD-Na) scores are routinely utilized, they may fail to capture the complex inflammatory response and multiorgan involvement inherent to ACLF.
To improve prognostic estimation, novel predictive tools, including the CLIF-C ACLF-D score and the MELD-complication score, have been introduced, incorporating inflammatory parameters and complication markers. Validation of these prognostic models across distinct patient populations is necessary prior to broad implementation. This study evaluates the prognostic performance of these novel models in patients with ACLF admitted to the Intensive Care Unit (ICU).
All enrolled participants will undergo systematic evaluation upon admission:
Participants will be followed throughout their hospital stay and up to 28 days following admission. Survival outcomes will be confirmed in-hospital or post-discharge via telephone follow-up or clinical visits.
165 studies on the registry are indexed under Acute-On-Chronic Liver Failure; 60 are open to participants now.
This study's planned enrollment of 100 is below the median of 226 across 64 observational studies indexed under Acute-On-Chronic Liver Failure.
Browse Acute-On-Chronic Liver Failure studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 28 days post-hospital admission
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.
Time frame: 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
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.
Time frame: Baseline (day 1 of admission) up to 28 days
No study locations are listed for this record.
Start is estimated for Aug 2026; primary completion for Aug 2027, 12 months later.
Of 38 observational studies under Acute-On-Chronic Liver Failure, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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