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

Primary Purpose

Spontaneous Bacterial Peritonitis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ascitic fluid calprotectin
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spontaneous Bacterial Peritonitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

case

control

Arm Description

people who have spontaneous bacterial peritonitis

people who donot have spontaneous bacterial peritonitis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 14, 2022
Last Updated
August 10, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05422118
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Bacterial Peritonitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
case
Arm Type
Active Comparator
Arm Description
people who have spontaneous bacterial peritonitis
Arm Title
control
Arm Type
Active Comparator
Arm Description
people who donot have spontaneous bacterial peritonitis
Intervention Type
Diagnostic Test
Intervention Name(s)
ascitic fluid calprotectin
Intervention Description
ascitic fluid calprotectin
Primary Outcome Measure Information:
Title
1-CBC
Description
WBCs count and differential,RBCs count,HB,mcv,Mch,Mchc,platelete count
Time Frame
6 months
Title
2-liver function test
Description
AlT,ASt,Albumin,total protein,bilirubin
Time Frame
6 months
Title
3-Renal function test
Description
serum create and urea
Time Frame
6 months
Title
4-Ascitic fluid analysis(physical,chemical,microscopic)
Description
physical(colour,aspect) chemical(protien,glucose) microscopical(wbcs total and differential,Rbcs),bacterial culture
Time Frame
6 months
Title
Ascitic Fluid calprotectin
Description
ascitic fluid calprotectin by ELISA
Time Frame
6 months
Title
INR
Description
international normalization time
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa S Mohamed, resident
Phone
01159603636
Email
alaasabr@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
laila M Yousef, professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R Elshrif, professor

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
8666323
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.
Results Reference
background
PubMed Identifier
20865473
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.
Results Reference
background
PubMed Identifier
20633946
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.
Results Reference
background
PubMed Identifier
30666172
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.
Results Reference
background

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

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