Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT04775420
Status:
COMPLETED
Last Update Posted:
2023-01-23
First Post:
2021-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MPV and NLR as Predictors of SBP Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D063847', 'term': 'Mean Platelet Volume'}], 'ancestors': [{'id': 'D010979', 'term': 'Platelet Function Tests'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D048429', 'term': 'Cell Size'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 332}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-20', 'studyFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2021-02-26', 'lastUpdatePostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The utility of MPV as non-invasive predictor of SBP', 'timeFrame': '1 year', 'description': 'It will be measured from CBC'}, {'measure': 'The utility of NLR as non-invasive predictor of SBP', 'timeFrame': '1 year', 'description': 'It will be measured from CBC'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spontaneous bacterial peritonitis', 'Mean platelet volume', 'Neutrophil to lymphocyte ratio'], 'conditions': ['Spontaneous Bacterial Peritonitis']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the clinical utility of mean platelet volume (MPV) and neutrophil to lymphocyte ratio (NLR) as diagnostic markers for spontaneous bacterial peritonitis (SBP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ascites due to decompensated liver cirrhosis admitted at the inpatient section of Tropical Medicine and Gastroenterology Department, Sohag University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Decompensated liver cirrhosis ascetic patients.\n\nExclusion Criteria:\n\n* Immunocompromised patients.\n* Patients who had received antibiotics before hospital admission.\n* Patients on anticoagulant medications, NSAIDs, or oral contraceptive drugs.\n* Patients with heart failure, diabetes mellitus, hypertension, hyperlipidemia, peripheral vascular disease, hematological disorders, and neoplastic disorders and patients with clinically overt hypothyroidism or hyperthyroidism or with clinically and laboratory-evident autoimmune diseases.'}, 'identificationModule': {'nctId': 'NCT04775420', 'briefTitle': 'MPV and NLR as Predictors of SBP Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Mean Platelet Volume (MPV) and Neutrophil to Lymphocyte Ratio (NLR) as Predictors of Spontaneous Bacterial Peritonitis in Cirrhotic Patients', 'orgStudyIdInfo': {'id': 'Soh-Med-21-02-22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Ascetic patients without spontaneous bacterial peritonitis', 'interventionNames': ['Diagnostic Test: Measurement of mean platelet volume (MPV) and blood neutrophil to lymphocyte ratio (NLR)']}, {'label': 'Group 2', 'description': 'Ascetic patients with spontaneous bacterial peritonitis', 'interventionNames': ['Diagnostic Test: Measurement of mean platelet volume (MPV) and blood neutrophil to lymphocyte ratio (NLR)']}], 'interventions': [{'name': 'Measurement of mean platelet volume (MPV) and blood neutrophil to lymphocyte ratio (NLR)', 'type': 'DIAGNOSTIC_TEST', 'description': 'MPV and NLR are easily accessible and inexpensive tests', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82524', 'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag Faculty of Medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmed Abudeif Abdelaal, MD', 'investigatorAffiliation': 'Sohag University'}}}}