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

  1. To determine the prognostic performance of novel scores in predicting complications and in-hospital mortality in patients with liver cirrhosis.
  2. To compare the accuracy of these scores in identifying high risk patients relative to the standard scores.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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