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NCT Number: NCT06679868

Role of ALBI Score and Sarcopenia As Prognostic Predictors Among Hospitalized Cirrhotic Patients With Hepatic Encephalopathy

To evaluate the role of ALBI score in predicting prognosis and hospital mortality of hospitalized cirrhotic patients with hepatic encephalopathy.

To verify the best scoring system for predicting prognosis and survival among those patients.

To investigate whether the presence of sarcopenia could add to the prognostic role of ALBI score.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

Hepatic encephalopathy (HE) is a brain dysfunction caused by impaired liver functions and/or portosystemic shunting. It is one of the most serious complications of liver cirrhosis that leads to a signifcantly impaired quality of life and frequent hospitalizations.

Although the pathogenesis of HE is complex ,accumulation of ammonia ,systemic inflammation, and oxidative stress play a pivotal role .Multiple organs are involved in whole body homeostasis of ammonia, with the liver being a key site .As cirrhosis leads to decline in capacity of liver to detoxify ammonia, skeletal muscle plays a compensatory in ammonia metabolism and clearance .Liver function largely reflect prognosis of liver disease,The ALBI score was originally developed as a measure of liver function in patients with HE.It was developed by putting all of the original components of the Child-Pugh (CTP) score into a multivariable model, the clinical features, (Ascites, Encephalopathy and INR) ,were shown to be redundant in that the entire prognostic value of the CTP score could be explained by just albumin and bilirubin levels in an appropriate formulation derived from multivariable model.As with the CTP and MELD scores, both of which were introduced for specific clinical situation and extended to more general application, the same has happened with ALBI.Increasingly, ALBI score is applied as a preferred measure of liver function due to its objectivity and sensitivity for minor liver function deterioration . In comparison to the MELD score, The ALBI score is sufficiently sensitive of liver function ,thus it might be expected to predict longer-term mortality in patients with cirrhosis, better than the MELD score, which would be expected to predict shorter-term mortality in patients with decompensated cirrhosis or liver failure. A study showed clearly that the ALBI score is the most accurate scoring system in predicting prognosis, followed by CTP, CLIF-SOFA, MELD-Na. Furthermore, it has been shown that the ALBI score is the strongest independent predictor of mortality among other scores. The presence of sarcopenia leads to higher risk of HE. Muscle depletion defined by mid arm circumference is associated with development of covert and overt HE

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All cirrhotic patients with hepatic encephalopathy admitted to Al-Rajhi liver hospital.

Exclusion criteria

  • Patients with acute hepatic failure and those with previous portosystemic surgery or TIPS.
  • Patients with prior liver or other organs transplantation.
  • End stage renal disease(ESRD), and HCC or other solid tumors.
  • Patients on marivan for any cause.
  • Patients with extra-hepatic biliary obstruction.

Treatment and study plan

Primary outcomes

  1. 1- Evaluation of the role of ALBI score in predicting prognosis and hospital mortality of hospitalized cirrhotic patients with hepatic encephalopathy. 2- Verification of the best scoring system for predicting prognosis and survival among those patients

    Time frame: ALBI score/at admission and follow up of patients /after 1 month

    ALBI score can be assessed by following formula : 0.66Xlog(bilirubin.mg/dl)_0.085X(albumin.g/dl)The cut-off points for ALBI grades are:Grade I : less than -2.60(lowest mortality risk)Grade II : -2.60 to - 1.39(Intermediate)Grade III : more than -1.39 (Highest ) Follow up of those patients and record of improvement, deterioration or death will be done.

Study contacts

Contact information is provided by the study sponsor or research team.

Hanan Mohammed Nafeh, Professor

CONTACT

[email protected]

00201003053369

Heba Saad Abu Elsoud, Resident Doctor

CONTACT

[email protected]

00201064375775

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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