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

NCT06778616 | Not Yet Recruiting DMC

• 1 other identifier: Recurrence of SBP
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 2

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

Conditions

Spontaneous Bacterial Peritonitis

Outcome Measures

Primary Outcomes (1)

• Frequency and Predictors of Recurrent Spontaneous Bacterial Peritonitis in Cirrhotic Patients in Al Rajhi University Hospital.

  Determine the frequency of recurrent SBP after its management within one year

  One year

Secondary Outcomes (1)

• Predictors of recurrent SBP

  One year

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• Any patient with one or more of the following criteria will be excluded:
• 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.
• Patients presenting with empyema or bacterial peritonitis secondary to an intra-abdominal organ perforation or surgical operation

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Assiut Faculty of Medicine

Asyut, Asyut Governorate, 71515, Egypt

Location

Assiut University

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (1)

• 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.

  PMID: 37180608 BACKGROUND

Study Officials

• Marwa A Ahmed, MD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Asmaa M Hussein, MSc

CONTACT

00201070041233; asmaamoussa299@gamil.com

Marwa A Ahmed, MD

CONTACT

00201155544090; Marwamakhlof088@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: January 16, 2025
• Study Start: February 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

EG (2)