Laboratory Diagnosis of Spontaneous Bacterial Peritonitis

Spontaneous Bacterial Peritonitis Clinical Trial

— SBP  

Official title:

Diagnostic Performance of Different Scores for Predicting Spontaneous Bacterial Peritonitis in Cirrhotic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05696054
• Other study ID #: 246810
• Status: Not yet recruiting
• Start date: February 15, 2023
• Est. completion date: September 15, 2023

Study information

• Verified date: January 2023
• Source: Sohag University
• Contact: Amira Maher, MD
• Phone: 00201006789652
• Email: amiramaher[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peritonitis
• Spontaneous Bacterial Peritonitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PEC index	procalcitoin × (ESR + CRP)	five months
Primary	Modified Wehmeyer score	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	five months
Primary	Mansoura score	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	five months