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

NCT ID: NCT07116369

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Spontaneous Bacterial Peritonitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ascites patients

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Shimaa Helmy Mahmoud

Internal Medicine Resident Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag university hospitals

Sohag, , Egypt

Countries

Egypt

Central Contacts

Shimaa H Mahmoud, MBBS

Role: CONTACT

shaimaa_helmy_post@med.sohag.edu.eg

+201120237891

Facility Contacts

Shimaa H Mahmoud, MBBS

Role: primary

shaimaa_helmy_post@med.sohag.edu.eg

+201120237891

Other Identifiers

Soh-Med--25-7-10MS

Identifier Type: -

Identifier Source: org_study_id