Comparative Study of Novel Prognostic Scores in Patients With Liver Cirrhosis

NCT ID: NCT07238543

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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* 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.

Conditions

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Liver Cirrhosis

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Usage of new scores

usage of new scores for prediction of morbidity and mortality in patients with liver cirrhosis

Intervention Type OTHER

Eligibility Criteria

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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:
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Andrew Hany Youssef Mina

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Andrew hany Mina, Bachelor of Medicine

Role: CONTACT

+201149072475

Ehab Fawzy Mostafa, Prof Dr

Role: CONTACT

+201142929 289

References

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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.

Reference Type RESULT
PMID: 24950482 (View on PubMed)

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.

Reference Type RESULT
PMID: 30266282 (View on PubMed)

Other Identifiers

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New scores in liver cirrhosis

Identifier Type: -

Identifier Source: org_study_id

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