Clinical trial NCT05422118: Ascitic Fluid Calprotectin as an Accurate Diagnostic Marker for Spontaneous Bacterial Peritonitis
Official title: Ascitic Fluid Calprotectin as an Accurate Diagnostic Marker for Spontaneous Bacterial Peritonitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spontaneous Bacterial Peritonitis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 .


Eligibility criteria: 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.

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.

Primary outcomes:
measure: 1-CBC
timeFrame: 6 months
measure: 2-liver function test
timeFrame: 6 months
measure: 3-Renal function test
timeFrame: 6 months
measure: 4-Ascitic fluid analysis(physical,chemical,microscopic)
timeFrame: 6 months
measure: Ascitic Fluid calprotectin
timeFrame: 6 months
measure: INR
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.