Clinical trial NCT07024355: Predicting and Monitoring Spontaneous Bacterial Peritonitis in Cirrhotic Patients Using the Mansoura Scoring System
Official title: Predicting and Monitoring Spontaneous Bacterial Peritonitis in Cirrhotic Patients Using the Mansoura Scoring System
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Spontaneous Bacterial Peritonitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective study included all adult patients with cirrhosis and ascites admitted to AL-Rajhy Liver Hospital between April 2025 and April 2027

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of Patients With Mansoura Score ≥4 Diagnosed With Spontaneous Bacterial Peritonitis (SBP)
timeFrame: At hospital admission( within 24 hours)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Amira M Abdelmawgod, Lecturer, Trop Med
role: PRINCIPAL_INVESTIGATOR
References: