Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-03-12 @ 10:16 AM
Study NCT ID:
NCT05422118
Status:
UNKNOWN
Last Update Posted:
2022-08-12
First Post:
2022-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ascitic Fluid Calprotectin as an Accurate Diagnostic Marker for Spontaneous Bacterial Peritonitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-01-10', 'releaseDate': '2023-04-04'}], 'estimatedResultsFirstSubmitDate': '2023-04-04'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2022-06-14', 'studyFirstSubmitQcDate': '2022-06-14', 'lastUpdatePostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1-CBC', 'timeFrame': '6 months', 'description': 'WBCs count and differential,RBCs count,HB,mcv,Mch,Mchc,platelete count'}, {'measure': '2-liver function test', 'timeFrame': '6 months', 'description': 'AlT,ASt,Albumin,total protein,bilirubin'}, {'measure': '3-Renal function test', 'timeFrame': '6 months', 'description': 'serum create and urea'}, {'measure': '4-Ascitic fluid analysis(physical,chemical,microscopic)', 'timeFrame': '6 months', 'description': 'physical(colour,aspect) chemical(protien,glucose) microscopical(wbcs total and differential,Rbcs),bacterial culture'}, {'measure': 'Ascitic Fluid calprotectin', 'timeFrame': '6 months', 'description': 'ascitic fluid calprotectin by ELISA'}, {'measure': 'INR', 'timeFrame': '6 months', 'description': 'international normalization time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spontaneous Bacterial Peritonitis']}, 'referencesModule': {'references': [{'pmid': '8666323', 'type': 'BACKGROUND', '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.'}, {'pmid': '20865473', 'type': 'BACKGROUND', '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.'}, {'pmid': '20633946', 'type': 'BACKGROUND', '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.'}, {'pmid': '30666172', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nSBP 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.\n\nThere are variants of ascitic fluid infections as culture-negative neutrocytic ascites, monomicrobial non-neutrocytic bacterascites, polymicrobial bacterascites and secondary bacterial peritonitis.\n\nThe 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.\n\nStudies 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.\n\nThe 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 .\n\nThere 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.\n\nCalprotectin 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 .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\-\n\nThe patients were divided into two groups:\n\n1. Non-SBP group: it included 25 patients with cirrhotic ascites without clinical or laboratory evidence of SBP.\n2. 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.\n\nExclusion Criteria:\n\n* (1) Cirrhotic patients with and without SBP receiving antibiotics in last 1 week.\n\n (2) Recent abdominal surgery (\\<3 months). (3) abdominal malignancy \\[hepatocellular carcinoma (HCC), colorectal carcinoma, gastric carcinoma, pancreatic carcinoma, cholangiocarcinoma\\].\n\n (4) Intra-abdominal infected lesions, such as abscess, appendicitis, cholecystitis, and pancreatitis.\n\n (5) History of inflammatory bowel disease (Crohn's disease, ulcerative colitis).\n\n (6) patients with heart failure (HF), hematological, and autoimmune disorders were excluded."}, 'identificationModule': {'nctId': 'NCT05422118', 'briefTitle': 'Ascitic Fluid Calprotectin as an Accurate Diagnostic Marker for Spontaneous Bacterial Peritonitis', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Ascitic Fluid Calprotectin as an Accurate Diagnostic Marker for Spontaneous Bacterial Peritonitis', 'orgStudyIdInfo': {'id': 'Soh-Med-22-06-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'case', 'description': 'people who have spontaneous bacterial peritonitis', 'interventionNames': ['Diagnostic Test: ascitic fluid calprotectin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'people who donot have spontaneous bacterial peritonitis', 'interventionNames': ['Diagnostic Test: ascitic fluid calprotectin']}], 'interventions': [{'name': 'ascitic fluid calprotectin', 'type': 'DIAGNOSTIC_TEST', 'description': 'ascitic fluid calprotectin', 'armGroupLabels': ['case', 'control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Osama R Elshrif, professor', 'role': 'CONTACT'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Alaa S Mohamed, resident', 'role': 'CONTACT', 'email': 'alaasabr@med.sohag.edu.eg', 'phone': '01159603636'}, {'name': 'laila M Yousef, professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor at clinical pathology department at faculty of medicine sohag university hospital', 'investigatorFullName': 'Alaa Saber Mohamed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-04-04', 'type': 'RELEASE'}, {'date': '2024-01-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Alaa Saber Mohamed, resident doctor at clinical pathology department at faculty of medicine sohag university hospital, Sohag University'}}}}