Laboratory Diagnosis of Spontaneous Bacterial Peritonitis

Not yet recruiting

• Conditions: Spontaneous Bacterial Peritonitis

• Registration Number: NCT05696054
• Lead Sponsor: Sohag University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-01
• Study First Submitted QC: 2023-01-23
• Last Update Submitted: 2023-01-23
• Study First Posted: 2023-01-25
• Last Update Posted: 2023-01-25
• Study Start: 2023-02-15
• Primary Completion: 2023-07-15
• Study Completion: 2023-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• cirrhotic patients with ascites

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PEC index	five months	procalcitoin × (ESR + CRP)
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
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