Ascitic Fluid Calprotectin as an Accurate Diagnostic Marker for Spontaneous Bacterial Peritonitis

Not Applicable

• Conditions: Spontaneous Bacterial Peritonitis
• Interventions: Diagnostic Test: ascitic fluid calprotectin

• Registration Number: NCT05422118
• Lead Sponsor: Sohag University

Brief Summary

Spontaneous bacterial peritonitis (SBP) is an infection of the ascitic fluid in patients with liver cirrhosis and portal hypertension. There is no obvious surgical cause as perforation or intraabdominal inflammatory focus as abscess. Up to 30% of the ascitic patients will develop SBP.

SBP is attributed to immune dysfunction, bacterial translocation, circulatory dysfunction and inflammatory status. SBP is diagnosed by ascitic fluid analysis . SBP was defined as polymorphonuclear leucocyte count (PMN) \>250/mm3 in ascitic fluid, . Not all cases are associated with positive ascitic fluid cultures.

There are variants of ascitic fluid infections as culture-negative neutrocytic ascites, monomicrobial non-neutrocytic bacterascites, polymicrobial bacterascites and secondary bacterial peritonitis.

The advent of the SBP carries a poor prognosis where the hospital mortality ranged from 10 to 50%. As a consequence, any patient with SBP should be assessed for liver transplantation. Immediate treatment with antibiotics and IV albumin should be initiated.

Studies were conducted on alternatives of the ascitic PMN count as high sensitivity C-reactive protein (hsCRP), serum procalcitonin, urinary lipocalin, ascitic lactoferrin, homocysteine and fecal or ascitic calprotectin.

The gold standard test for SBP is ascitic fluid analysis with measurement of the PMN. It is useful for the diagnosis and monitoring of treatment. The culture of the ascitic fluid may be positive if was done correctly .

There is a variant of SBP that is called culture-negative neutrocytic ascites. It is characterized by elevated ascitic fluid PMN but the culture is negative. It is managed exactly as classic SBP. Such cases would be missed if cultures were not done The manual PMN counting is time consuming, laborious and required some experience to avoid intra- and inter-observer variability. So, a simple rapid bedside test would be useful clinically.

Calprotectin is acute-phase inflammatory protein that is released from the PMN. Calprotectin has anti-proliferative and antimicrobial properties. Calprotectin is used clinically widespread in the diagnosis and monitoring treatment of inflammatory bowel disease .

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-06-10
• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-16
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-12
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

The patients were divided into two groups:

1. Non-SBP group: it included 25 patients with cirrhotic ascites without clinical or laboratory evidence of SBP.
2. SBP group: it included 25 patients with cirrhotic ascites with SBP. They were diagnosed by positive ascitic fluid bacterial culture, an increase in PMNLs count in ascites (>250 cells/mm3) and without any intra-abdominal source of infection.

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Exclusion Criteria

• (1) Cirrhotic patients with and without SBP receiving antibiotics in last 1 week.

  (2) Recent abdominal surgery (<3 months). (3) abdominal malignancy [hepatocellular carcinoma (HCC), colorectal carcinoma, gastric carcinoma, pancreatic carcinoma, cholangiocarcinoma].

  (4) Intra-abdominal infected lesions, such as abscess, appendicitis, cholecystitis, and pancreatitis.

  (5) History of inflammatory bowel disease (Crohn's disease, ulcerative colitis).

  (6) patients with heart failure (HF), hematological, and autoimmune disorders were excluded.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
case	ascitic fluid calprotectin	people who have spontaneous bacterial peritonitis
control	ascitic fluid calprotectin	people who donot have spontaneous bacterial peritonitis

Primary Outcome Measures

Name	Time	Method
Ascitic Fluid calprotectin	6 months	ascitic fluid calprotectin by ELISA
INR	6 months	international normalization time
2-liver function test	6 months	AlT,ASt,Albumin,total protein,bilirubin
4-Ascitic fluid analysis(physical,chemical,microscopic)	6 months	physical(colour,aspect) chemical(protien,glucose) microscopical(wbcs total and differential,Rbcs),bacterial culture
1-CBC	6 months	WBCs count and differential,RBCs count,HB,mcv,Mch,Mchc,platelete count
3-Renal function test	6 months	serum create and urea

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt