NCT07116369

Brief Summary

This study aims to evaluate whether integrating serum sodium levels and platelet count with the Albumin-Bilirubin (ALBI) score can improve the early prediction of spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites. SBP is a common and potentially life-threatening complication of cirrhosis. Identifying at-risk patients early using simple, routine laboratory parameters could enhance risk stratification, guide monitoring strategies, and reduce associated morbidity and mortality. Participants will be Adult patients (≥18 years) with liver cirrhosis and ascites undergoing diagnostic paracentesis at Sohag University Hospital.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

July 25, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 11, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

July 25, 2025

Last Update Submit

August 8, 2025

Conditions

Keywords

Spontaneous bacterial peritonitisSBPLiver cirrhosisABLI scoreAscites

Outcome Measures

Primary Outcomes (1)

  • Occurrence of SBP, ALBI score, s.sodium, platelet count

    Outcome of SBP in cirrhotic patients by measurement of ALBI score, platelet count and s.sodium

    Within 1 week

Study Arms (1)

Ascites patients

\>18 yr old Patients with liver cirrhosis and ascites, peritoneal aspirate, ALBI score, plaltlet, serum sodium will be recorded

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients (≥18 years) with liver cirrhosis and ascites who underwent diagnostic paracentesis in sohag university hospitals

You may qualify if:

  • adult patients (≥18 years) with liver cirrhosis and ascites who underwent diagnostic paracentesis.

You may not qualify if:

  • obstructive jaundice
  • Recent antibiotic use \< 7 days
  • Secondary pertonitis (bowel perforation)
  • Advanced Hepatocelluar carcinoma
  • End-stage renal disease requiring dialysis
  • Use of immunosuppressive therapy
  • Incomplete laboratory or clinical data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university hospitals

Sohag, Egypt

Location

MeSH Terms

Conditions

Liver CirrhosisAscites

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internal Medicine Resident Doctor

Study Record Dates

First Submitted

July 25, 2025

First Posted

August 11, 2025

Study Start

August 1, 2025

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

August 11, 2025

Record last verified: 2025-07

Locations