Clinical trial NCT06778616: Frequency and Predictors of Recurrent SBP in Cirrhotic Patients in Al Rajhi University Hospital
Official title: Frequency and Predictors of Recurrent Spontaneous Bacterial Peritonitis in Cirrhotic Patients in Al Rajhi University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Spontaneous Bacterial Peritonitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 101
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any cirrhotic patient above the age of 18 years old of both sexes, having a first episode of SBP will be included in our study.

Brief summary: * Assess the frequency of recurrent SBP in ascitic cirrhotic patients.
* Determine the predictive factors of recurrence after the first episode of SBP in ascitic cirrhotic patients

Detailed description: Spontaneous bacterial peritonitis (SBP) is a common complication in cirrhotic patients. The prevalence of SBP in hospitalized patients and the mortality rate were reported to be 10%-30% and 30%-50%, respectively.

SBP has been considered a life-threatening infection that requires a prompt diagnosis and treatment.

Eligibility criteria: Inclusion Criteria:

* Any cirrhotic patient above the age of 18 years old of both sexes, having a first episode of SBP will be included in our study.

  1. The diagnosis of cirrhosis was based on clinical manifestation (ascites, splenomegaly, lower limb edema and/or esophageal varices by upper gastrointestinal endoscopy), laboratory findings and radiological (abdominal ultrasonography), or liver histology.
  2. The diagnosis of SBP was based on a neutrophil cell count of 250 cell or more per mm3 with or without culture positivity of ascitic fluid, in the absence of hemorrhagic ascites and secondary peritonitis.

Exclusion Criteria:

* Any patient with one or more of the following criteria will be excluded:

  1. Patients with bacterial ascites defined by a positive culture of ascitic fluid associated with a neutrophil cell count less than 250 cell per mm3 in the ascitic fluid.
  2. Patients presenting with empyema or bacterial peritonitis secondary to an intra-abdominal organ perforation or surgical operation

Primary outcomes:
measure: Frequency and Predictors of Recurrent Spontaneous Bacterial Peritonitis in Cirrhotic Patients in Al Rajhi University Hospital.
timeFrame: One year
Secondary outcomes:
measure: Predictors of recurrent SBP
timeFrame: One year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Marwa A Ahmed, MD
role: STUDY_DIRECTOR
References:
citation: Moalla M, Elleuch N, Dahmani W, Hammami A, Ameur WB, Slama AB, Brahem A, Ajmi S, Ksiaa M, Jaziri H, Jmaa A. Predictive factors of recurrence in spontaneous bacterial peritonitis in Tunisian patients with cirrhosis. Future Sci OA. 2023 Apr 17;9(5):FSO857. doi: 10.2144/fsoa-2023-0016. eCollection 2023 Jun.