Apixaban to Prevent Decompensation of Early Liver Cirrhosis Trial
NCT07726693
Digestive System Diseases, Fibrosis
View Trial DetailsNCT Number: NCT06679868
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.
Trial opening soon.
Get Notified20 year–90 year
All sexes
Observational
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
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Contact information is provided by the study sponsor or research team.
Hanan Mohammed Nafeh, Professor
CONTACT
Heba Saad Abu Elsoud, Resident Doctor
CONTACT
Assiut University
Other
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