Liver CirrhosisNCT06679868
Role of ALBI Score and Sarcopenia As Prognostic Predictors Among Hospitalized Cirrhotic Patients With Hepatic Encephalopathy
An observational study of Liver Cirrhosis, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Adult, Older adult
Study population: Prospective
Who may be able to join
- All cirrhotic patients with hepatic encephalopathy admitted to Al-Rajhi liver hospital.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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
- Conditions
- Liver Cirrhosis
- Medical subject headings
- Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: ALBI score/at admission and follow up of patients /after 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Saad Ahmed Abu Elsoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679868
- Sponsor's protocol ID
- ALBI and Sarcopenia in LC
- Status last verified
- Nov 2024
- First submitted
- 6 Sep 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen H, Yang C, Yan S, Liu X, Zhou L, Yuan X. Sarcopenia in cirrhosis: From pathophysiology to interventional therapy. Exp Gerontol. 2024 Oct 15;196:112571. doi: 10.1016/j.exger.2024.112571. Epub 2024 Sep 9.
PubMed 39236869Hsieh YC, Lee KC, Wang YW, Yang YY, Hou MC, Huo TI, Lin HC. Correlation and prognostic accuracy between noninvasive liver fibrosismarkers and portal pressure in cirrhosis: Role of ALBI score. PLoS One. 2018 Dec 12;13(12):e0208903. doi: 10.1371/journal.pone.0208903. eCollection 2018.
PubMed 30540824
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of ALBI Score and Sarcopenia As Prognostic Predictors Among Hospitalized Cirrhotic Patients With Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT06679868
- Acronym / sponsor ID
- ALBI and Sarcopenia in LC
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Prospective
Key inclusion criteria (1 listed)
- All cirrhotic patients with hepatic encephalopathy admitted to Al-Rajhi liver hospital.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Results publication: PubMed 39236869Chen H, Yang C, Yan S, Liu X, Zhou L, Yuan X. Sarcopenia in cirrhosis: From pathophysiology to interventional therapy. Exp Gerontol. 2024 Oct 15;196:112571. doi: 10.1016/j.exger.2024.112571. Epub 2024 Sep 9.
- Results publication: PubMed 30540824Hsieh YC, Lee KC, Wang YW, Yang YY, Hou MC, Huo TI, Lin HC. Correlation and prognostic accuracy between noninvasive liver fibrosismarkers and portal pressure in cirrhosis: Role of ALBI score. PLoS One. 2018 Dec 12;13(12):e0208903. doi: 10.1371/journal.pone.0208903. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heba Saad Abu Elsoud, Resident Doctor (00201064375775, hsaad7355@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06679868, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.