Prediction of SBP in Cirrhotic Patients by Platlet Count, Na and AlBl Index.

Enhancing Prediction of Spontaneous Bacterial Peritonitis in Liver Cirrhosis by Integrating Serum Sodium and Platelet Count With the Albumin-Bilirubin Score .

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spontaneous Bacterial Peritonitis

Detailed Description

This is a prospective observational study designed to enhance the prediction of spontaneous bacterial peritonitis (SBP) in patients with liver cirrhosis and ascites by integrating serum sodium levels and platelet count with the Albumin-Bilirubin (ALBI) score. SBP remains a serious and potentially fatal complication in cirrhotic patients, with delayed diagnosis contributing to poor outcomes. The ALBI score, which reflects liver function objectively, along with hyponatremia and thrombocytopenia-common in cirrhosis-may provide a simple, low-cost method for early identification of patients at high risk for SBP.

The study will be conducted over 6 months at the Internal Medicine and Hepatology Units, Sohag University Hospital. All eligible adult patients (≥18 years) with liver cirrhosis and ascites who undergo diagnostic paracentesis will be screened for inclusion.

Inclusion criteria include cirrhotic patients with ascites undergoing diagnostic paracentesis.

Exclusion criteria include secondary peritonitis, advanced hepatocellular carcinoma, obstructive jaundice, recent antibiotic use (<7 days), end-stage renal disease requiring dialysis, current use of immunosuppressive therapy, and incomplete data.

Each participant will undergo clinical evaluation and laboratory testing, including serum albumin, bilirubin (for ALBI calculation), sodium, and platelet count. Ascitic fluid analysis will be performed to diagnose SBP based on PMN count ≥250 cells/mm³.

The study will assess whether a combined score (ALBI-Na-Platelet) can improve prediction accuracy. Statistical analysis will involve logistic regression and ROC curve analysis to evaluate the predictive power of the combined parameters.

All participants will provide written informed consent. The study is approved by the Medical Ethics Committee of Sohag University, Faculty of Medicine.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Shimaa H Mahmoud, MBBS; Phone Number: +201120237891; Email: shaimaa_helmy_post@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag university hospitals
    • Contact: Shimaa H Mahmoud, MBBS; Phone Number: +201120237891; Email: shaimaa_helmy_post@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Ascites patients; >18 yr old Patients with liver cirrhosis and ascites, peritoneal aspirate, ALBI score, plaltlet, serum sodium will be recorded

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 25, 2025
• First Submitted That Met QC Criteria: August 8, 2025
• First Posted (Actual): August 11, 2025

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Ascites; SBP; Liver cirrhosis; Spontaneous bacterial peritonitis; ABLI score
• Additional Relevant MeSH Terms: Infections; Digestive System Diseases; Peritoneal Diseases; Intraabdominal Infections; Peritonitis
• Other Study ID Numbers: Soh-Med--25-7-10MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No