Frequency and Predictors of Recurrent SBP in Cirrhotic Patients in Al Rajhi University Hospital

NCT ID: NCT06778616

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 101 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2025-11-30

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.

Conditions

Spontaneous Bacterial Peritonitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

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

• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Asmaa Moussa Hussein Hassan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwa A Ahmed, MD

Role: STUDY_DIRECTOR

Assiut University

Locations

Assiut Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Assiut University

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Central Contacts

Asmaa M Hussein, MSc

Role: CONTACT

asmaamoussa299@gamil.com

00201070041233 ext. 002

Marwa A Ahmed, MD

Role: CONTACT

Marwamakhlof088@gmail.com

00201155544090 ext. 002

Facility Contacts

Asmaa M Hassan, Msc

Role: primary

asmaamoussa299@gamil.com

00201070041233 ext. 002

Marwa A Ahmed, MD

Role: backup

Marwamakhlof088@gmail.com

01004673807 ext. 002

Marwa A Ahmed, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 37180608 (View on PubMed)

Other Identifiers

Recurrence of SBP

Identifier Type: -

Identifier Source: org_study_id