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

January 12, 2025 updated by: Asmaa Moussa Hussein Hassan, Assiut University

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

  • 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

Study Overview

Status

Not yet recruiting

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.

Study Type

Observational

Enrollment (Estimated)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Assiut, Egypt, 71515
        • Assiut University
        • Contact:
          • Marwa A Ahmed, MD
      • Assiut, Egypt, 71515

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency and Predictors of Recurrent Spontaneous Bacterial Peritonitis in Cirrhotic Patients in Al Rajhi University Hospital.
Time Frame: One year
Determine the frequency of recurrent SBP after its management within one year
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictors of recurrent SBP
Time Frame: One year
Determining risk factors of recurrent SBP
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Marwa A Ahmed, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

January 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 12, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Recurrence of SBP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spontaneous Bacterial Peritonitis

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