Predicting and Monitoring Spontaneous Bacterial Peritonitis in Cirrhotic Patients Using the Mansoura Scoring System

Not yet recruiting

• Conditions: Spontaneous Bacterial Peritonitis

• Registration Number: NCT07024355
• Lead Sponsor: Assiut University

Brief Summary

The aim of this prospective study was to examine predictors of SBP in order to develop a noninvasive method to identify or exclude an episode of SBP, for starting early treatment with antibiotics, so decrease morbidity and mortality in these patients.

Detailed Description

Spontaneous bacterial peritonitis (SBP) is a bacterial infection of ascitic fluid without any intra-abdominal, surgically treatable cause.

SBP is the most common bacterial infection in patients with cirrhosis, with a mortality rate exceeding 90% in untreated cases. However, inpatient mortality has been reduced to about 20% with early diagnosis and effective treatment.

Delayed diagnosis increases in-hospital mortality; with each hour of delay in performing paracentesis for SBP diagnosis, mortality increases by approximately 3.3%.

A study conducted in the United States reported that paracentesis was performed within the first 24 hours of admission in only 66% of cirrhotic patients with ascites.

Another study noted that routine paracentesis cannot be performed in all patients with liver cirrhosis. Therefore, delaying diagnosis increases mortality, and it is necessary to find a non-invasive and accurate method for predicting SBP.

Important risk factors for the development of SBP in cirrhotic patients include a history of SBP, variceal hemorrhage, and the use of proton pump inhibitors Several laboratory parameters have been evaluated as early predictors of SBP, including C-reactive protein (CRP), neutrophil-to-lymphocyte ratio (NLR), mean platelet volume (MPV), platelet count, and serum creatinine level. However, the data remain inconsistent.

Recently, the Mansoura Scoring System was developed at Mansoura University and retrospectively applied to cirrhotic patients with ascites for early SBP diagnosis without waiting for peritoneal fluid analysis.

The Mansoura score includes four components: age, MPV, and NLR (1 point each), and CRP (2 points), yielding a total score of 0 to 5. SBP is diagnosed when the score is equal to or greater than 4.

Study Timeline

• Study First Submitted: 2025-04-23
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-09
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Study Start: 2026-04-01
• Primary Completion: 2026-04-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Patients with cirrhosis Presence of ascites Age > 18 years Provided informed consent

Exclusion Criteria

Use of antibiotics within the previous two weeks Prophylactic treatment for SBP before admission Ascites not related to portal hypertension (e.g., peritoneal tuberculosis, peritoneal carcinomatosis, congestive heart failure, renal disease, pancreatitis, or hemorrhagic ascites) Secondary peritonitis Infections other than SBP (e.g., pneumonia, urinary tract infection, skin infection) Presence of malignancy Hematologic diseases Use of antiplatelet drugs or non-steroidal anti-inflammatory drugs (NSAIDs) Receipt of platelet or blood transfusion prior to admission Diseases associated with elevated MPV (e.g., diabetes mellitus, cardiovascular disease, hyperthyroidism, immune thrombocytopenia, myeloproliferative disease)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Mansoura Score ≥4 Diagnosed With Spontaneous Bacterial Peritonitis (SBP)	At hospital admission( within 24 hours)	Primary Outcome Measures; Primary Outcome Measure 1: Title: Number of Patients With Mansoura Score ≥4 Diagnosed With Spontaneous Bacterial Peritonitis (SBP).The score ranges from 0 to 4, with higher scores indicating a higher likelihood of SBP (worse outcome). A score ≥4 is considered suggestive of SBP Time Frame: At hospital admission (within 24 hours) Description: Count of patients with a Mansoura score ≥4 who are diagnosed with spontaneous bacterial peritonitis (SBP), defined as ascitic fluid neutrophil count \>250 cells/mm³.; Unit of Measure: Number of patients; Primary Outcome Measure 2: Title: Proportion of Patients With Mansoura Score ≥4 Diagnosed With Spontaneous Bacterial Peritonitis (SBP) Time Frame: At hospital admission (within 24 hours) Description: Proportion of patients with a Mansoura score ≥4 who are diagnosed with spontaneous bacterial peritonitis (SBP), expressed as a percentage of total study participants.; Unit of Measure: Percentage of participants.