NCT06679868

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

11 months

First QC Date

September 6, 2024

Last Update Submit

November 6, 2024

Conditions

Outcome Measures

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

    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.

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

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 39236869BACKGROUND
  • Hsieh 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.

    PMID: 30540824BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Heba Saad Abu Elsoud, Resident Doctor

CONTACT

Hanan Mohammed Nafeh, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
HSAAD

Study Record Dates

First Submitted

September 6, 2024

First Posted

November 8, 2024

Study Start

November 1, 2024

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

November 8, 2024

Record last verified: 2024-11