- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07238543
Comparative Study of Novel Prognostic Scores in Patients With Liver Cirrhosis
November 16, 2025 updated by: Andrew Hany Youssef Mina, Assiut University
Comparative Study of Novel Prognostic Scores for Prediction of Morbidity and Mortality in Patients With Liver Cirrhosis
- To determine the prognostic performance of novel scores in predicting complications and in-hospital mortality in patients with liver cirrhosis.
- To compare the accuracy of these scores in identifying high risk patients relative to the standard scores.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
- Liver cirrhosis represents the end stage of chronic liver diseases and remains a major global health burden, accounting for over 1 million deaths annually.
- It is characterized by progressive fibrosis, nodular regeneration, and architectural distortion of the liver parenchyma, ultimately leading to liver dysfunction and portal hypertension
- Once acute decompensation occurs the prognosis significantly worsens, with a sharp increase in short-term mortality
- Accurate outcome prediction in cirrhotic patients is essential for guiding early interventions, allocating healthcare resources, and prioritizing liver transplant listing.
- Traditional prognostic scores, such as the Child-Turcotte Pugh (CTP) and Model for End-Stage Liver Disease (MELD), have important limitations.
- CTP includes subjective variables, while MELD may not fully reflect clinical deterioration in early decompensation
- MELD is widely used to predict the short-term mortality in patients with cirrhosis, but potential limitations of this score have been reported.
- An integrated MELD model (iMELD) including serum sodium and age improves the prediction of early mortality in patients with cirrhosis The Chronic Liver Failure Consortium Acute Decompensation (CLIF-C AD) score, introduced by European Association for the Study of the Liver (EASL), was specifically designed for hospitalized patients with acute decompensation (without Faculty of Medicine Institutional Review Board (IRB) Assiut Medical School Research Proposal Form 3 ACLF). It incorporates age, white blood cell count, and organ function to better stratify risk
- Recently, newer prognostic models such as the ADRECIA score have been developed, incorporating variables such as inflammatory markers and kidney function. These models aim to further refine risk stratification in cirrhosis, especially in early decompensation, before organ failure sets in
- Although these novel scores show promise in identifying patients at high risk for deterioration or death, direct comparisons in real-world clinical settings are lacking.
- Understanding their relative performance could help optimize the management of hospitalized patients with AD cirrhosis, thereby facilitating early clinical decision-making, optimizing patient outcomes, and potentially improving resource allocation in hepatology care settings.
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Andrew hany Mina, Bachelor of Medicine
- Phone Number: +201149072475
- Email: androwhany988@gmail.com
Study Contact Backup
- Name: Ehab Fawzy Mostafa, Prof Dr
- Phone Number: +201142929 289
- Email: ehabmostafa@aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
This study based on patients with Liver Cirrhosis
Description
Inclusion Criteria:
• Age ≥ 18 years
- Diagnosis of liver cirrhosis (clinical, radiological using ultrasound or fibroscan)
- Hospital admission for acute decompensation (ascites, hepatic encephalopathy, variceal bleeding, SBP)
Exclusion C• Previous liver transplantation
- Pregnancy
- Refusal to participate in the study riteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparative study of novel prognostic scores for prediction of morbidity and mortality in patients with liver cirrhosis
Time Frame: baseline
|
Usage of new prognostic scores for prediction of morbidity and mortality in patients with LC
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jalan R, Saliba F, Pavesi M, Amoros A, Moreau R, Gines P, Levesque E, Durand F, Angeli P, Caraceni P, Hopf C, Alessandria C, Rodriguez E, Solis-Munoz P, Laleman W, Trebicka J, Zeuzem S, Gustot T, Mookerjee R, Elkrief L, Soriano G, Cordoba J, Morando F, Gerbes A, Agarwal B, Samuel D, Bernardi M, Arroyo V; CANONIC study investigators of the EASL-CLIF Consortium. Development and validation of a prognostic score to predict mortality in patients with acute-on-chronic liver failure. J Hepatol. 2014 Nov;61(5):1038-47. doi: 10.1016/j.jhep.2014.06.012. Epub 2014 Jun 17.
- Asrani SK, Devarbhavi H, Eaton J, Kamath PS. Burden of liver diseases in the world. J Hepatol. 2019 Jan;70(1):151-171. doi: 10.1016/j.jhep.2018.09.014. Epub 2018 Sep 26.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
November 16, 2025
First Submitted That Met QC Criteria
November 16, 2025
First Posted (Actual)
November 20, 2025
Study Record Updates
Last Update Posted (Actual)
November 20, 2025
Last Update Submitted That Met QC Criteria
November 16, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- New scores in liver cirrhosis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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