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

NCT05422118 | Unknown

• 1 other identifier: Soh-Med-22-06-07
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 .

Conditions

Spontaneous Bacterial Peritonitis

Outcome Measures

Primary Outcomes (6)

• 1-CBC

  WBCs count and differential,RBCs count,HB,mcv,Mch,Mchc,platelete count

  6 months

• 2-liver function test

  AlT,ASt,Albumin,total protein,bilirubin

  6 months

• 3-Renal function test

  serum create and urea

  6 months

• 4-Ascitic fluid analysis(physical,chemical,microscopic)

  physical(colour,aspect) chemical(protien,glucose) microscopical(wbcs total and differential,Rbcs),bacterial culture

  6 months

• Ascitic Fluid calprotectin

  ascitic fluid calprotectin by ELISA

  6 months

• INR

  international normalization time

  6 months

Study Arms (2)

case

ACTIVE COMPARATOR

people who have spontaneous bacterial peritonitis

Diagnostic Test: ascitic fluid calprotectin

control

ACTIVE COMPARATOR

people who donot have spontaneous bacterial peritonitis

Diagnostic Test: ascitic fluid calprotectin

Interventions

ascitic fluid calprotectin DIAGNOSTIC_TEST

ascitic fluid calprotectin

case; control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients were divided into two groups:
• Non-SBP group: it included 25 patients with cirrhotic ascites without clinical or laboratory evidence of SBP.
• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

• Xiol X, Castellvi JM, Guardiola J, Sese E, Castellote J, Perello A, Cervantes X, Iborra MJ. Spontaneous bacterial empyema in cirrhotic patients: a prospective study. Hepatology. 1996 Apr;23(4):719-23. doi: 10.1002/hep.510230410.

  PMID: 8666323 BACKGROUND

• Bernardi M. Spontaneous bacterial peritonitis: from pathophysiology to prevention. Intern Emerg Med. 2010 Oct;5 Suppl 1:S37-44. doi: 10.1007/s11739-010-0446-x.

  PMID: 20865473 BACKGROUND

• European Association for the Study of the Liver. EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis. J Hepatol. 2010 Sep;53(3):397-417. doi: 10.1016/j.jhep.2010.05.004. Epub 2010 Jun 1. No abstract available.

  PMID: 20633946 BACKGROUND

• Marciano S, Diaz JM, Dirchwolf M, Gadano A. Spontaneous bacterial peritonitis in patients with cirrhosis: incidence, outcomes, and treatment strategies. Hepat Med. 2019 Jan 14;11:13-22. doi: 10.2147/HMER.S164250. eCollection 2019.

  PMID: 30666172 BACKGROUND

Central Study Contacts

Alaa S Mohamed, resident

CONTACT

01159603636; alaasabr@med.sohag.edu.eg

laila M Yousef, professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at clinical pathology department at faculty of medicine sohag university hospital

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 16, 2022
• Study Start: June 10, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)