Laboratory Diagnosis of Spontaneous Bacterial Peritonitis

NCT ID: NCT05696054

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2023-09-15

Brief Summary

This study aims at evaluating the diagnostic accuracy of serum procalcitonin, PEC index, modified Wehmeyer, and Mansoura scoring systems for SBP in cirrhotic patients with ascites

Detailed Description

Based on clinical diagnosis, SBP is commonly underdiagnosed because of its nonspecific or asymptomatic presentation. Therefore, a diagnostic paracentesis should be performed in all cirrhotic patients with ascites who require emergency room care or hospitalization, who demonstrate signs/symptoms suggesting SBP, or who present gastrointestinal bleeding, in order to exclude SBP. Several non-invasive methods were tried in many studies for SBP diagnosis, as alternatives to diagnostic paracentesis, e.g., fecal calprotectin. Moreover, numerous scores were proposed for SBP diagnosis with variable accuracies, such as procalcitonin, ESR, and CRP (PEC) index, the modified Wehmeyer SBP scoring system, and Mansoura scoring system. This study aims at evaluating the diagnostic accuracy of serum procalcitonin, PEC index, modified Wehmeyer, and Mansoura scoring systems for SBP in cirrhotic patients with ascites. participants will be subjected to: Clinical evaluation: medical history and physical examination, Routine Laboratory investigations, Serum procalcitonin, Ascitic fluid study, Ascitic fluid culture with antibiotic sensitivity, Abdominal ultrasonography. The following scores will be calculated: Modified Child Pugh score, MELD score, MELD Na score, PEC index, Modified Wehmeyer score, and Mansoura score.

Conditions

Spontaneous Bacterial Peritonitis

Study Design

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

Study Groups

SBP group

Patients diagnosed as spontaneous bacterial peritonitis based on ascitic fluid study.

No interventions assigned to this group

non-SBP group

Patients without spontaneous bacterial peritonitis based on ascitic fluid study

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• cirrhotic patients with ascites

Exclusion Criteria

Infections other than SBP.

• malignancy.
• Antibiotic therapy before hospital admission.
• Chemotherapy or radiotherapy within 1 month before admission.
• Pancreatic diseases.
• contraindication to paracentesis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Amira Maher

Lecturer of Tropical Medicine and Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Amira Maher, MD

Role: CONTACT

amiramaher@med.sohag.edu.eg

00201006789652

Other Identifiers

246810

Identifier Type: -

Identifier Source: org_study_id