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SBP: Laboratory Diagnosis of Spontaneous Bacterial Peritonitis

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05696054
Collaborator
(none)
80
Enrollment
7
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Diagnostic Performance of Different Scores for Predicting Spontaneous Bacterial Peritonitis in Cirrhotic Patients
    Anticipated Study Start Date :
    Feb 15, 2023
    Anticipated Primary Completion Date :
    Jul 15, 2023
    Anticipated Study Completion Date :
    Sep 15, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    SBP group

    Patients diagnosed as spontaneous bacterial peritonitis based on ascitic fluid study.
    non-SBP group

    Patients without spontaneous bacterial peritonitis based on ascitic fluid study

    Outcome Measures

    Primary Outcome Measures

    1. PEC index [five months]

      procalcitoin × (ESR + CRP)

    2. Modified Wehmeyer score [five months]

      a score is calculated based on age, CRP level, and platelet count using a scale from 0 to 5 as follows: age >60 years: 1 point. platelet count <100,000/mL: 1 point CRP between 13.5 and30 mg/L: 1 point CRP between 30 and 60 mg/L: 2 points CRP above 60 mg/L: 3 points

    3. Mansoura score [five months]

      score is calculated based on age, mean platelets volume, neutrophil lymphocytic ratio, and CRP using a scale of 0 to 5 as follows: Age ≥55 years: 1 point MPV ≥8.5 fl: 1 point NLR≥2.5: 1 point CRP≥40 mg/l: 2 points

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amira Maher, Lecturer of Tropical Medicine and Gastroenterology, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05696054
    Other Study ID Numbers:
    • 246810
    First Posted:
    Jan 25, 2023
    Last Update Posted:
    Jan 25, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Peritonitis

    Study Results

    No Results Posted as of Jan 25, 2023