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NCT Number: NCT06778616

Frequency and Predictors of Recurrent SBP 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

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Key information

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut Faculty of Medicine, Asyut, Asyut Governorate, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Predictors of recurrent SBP

    Time frame: One year

    Determining risk factors of recurrent SBP

Study contacts

Contact information is provided by the study sponsor or research team.

Asmaa M Hussein, MSc

CONTACT

[email protected]

00201070041233 ext. 002

Marwa A Ahmed, MD

CONTACT

[email protected]

00201155544090 ext. 002

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2025
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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