Nctid:
NCT06612307
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D018805", "term"=>"Sepsis"}, {"id"=>"D014115", "term"=>"Toxemia"}], "ancestors"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D018746", "term"=>"Systemic Inflammatory Response Syndrome"}, {"id"=>"D007249", "term"=>"Inflammation"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M20864", "name"=>"Sepsis", "asFound"=>"Sepsis", "relevance"=>"HIGH"}, {"id"=>"M16869", "name"=>"Toxemia", "asFound"=>"Sepsis", "relevance"=>"HIGH"}, {"id"=>"M10018", "name"=>"Hypersensitivity", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M20818", "name"=>"Systemic Inflammatory Response Syndrome", "relevance"=>"LOW"}, {"id"=>"M10293", "name"=>"Inflammation", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>161}, "targetDuration"=>"1 Week", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-09-25", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-08-20", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-21", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-08-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Sensitivity of either leucocyte subpopulation, platelet indices with early clinical outcome", "timeFrame"=>"1 week", "description"=>"Post hoc analysis .... \\< 50 %= poor sensitivity..... \\> 50%= strong sensitivity"}, {"measure"=>"Specificity of either leucocyte subpopulation, platelet indices with early clinical outcome", "timeFrame"=>"1 week", "description"=>"Post hoc analysis .... \\< 50 %= poor sensitivity..... \\> 50%= strong sensitivity"}], "secondaryOutcomes"=>[{"measure"=>"correlation between leucocytes at enrollment , 7 days with ICU mortality", "timeFrame"=>"1 week"}, {"measure"=>"correlation between platelet indices at enrollment , 7 days with ICU mortality", "timeFrame"=>"one week"}, {"measure"=>"correlation between platelet indices at enrollment , 7 days with incidence of mechanical ventilation", "timeFrame"=>"1 week"}, {"measure"=>"correlation between leucocytes at enrollment , 7 days with incidence of mechanical ventilation", "timeFrame"=>"1week"}, {"measure"=>"correlation between leucocytes at enrollment , 7 days with incidence of acute kidney injury", "timeFrame"=>"1 week"}, {"measure"=>"correlation between platelet indices at enrollment , 7 days with incidence of acute kidney injury", "timeFrame"=>"1 week"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Sepsis"]}, "descriptionModule"=>{"briefSummary"=>"Leucocyte subpopulation and platelet indices analysis can predict clinical outcome"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"20 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"population admitted to the ICU with a diagnosis of sepsis were screened for inclusion within 48 h of presentation to the hospital. Sepsis was defined as per the Sepsis-3 definition, 6 ie, the presence of suspected or documented infection with organ dysfunction determined by an acute increase of sequential organ failure assessment (SOFA) score by 2 or more points", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Adult population of both sex, aged 20 or older admitted to the ICU with a diagnosis of sepsis were screened for inclusion within 48 h of presentation to the hospital. Sepsis was defined as per the Sepsis-3 definition, 6 ie, the presence of suspected or documented infection with organ dysfunction determined by an acute increase of sequential organ failure assessment (SOFA) score by 2 or more points\n\nExclusion Criteria:\n\n* Patient refusal.\n* History of surgery in the last 7 days from admission.\n* Immunocompromised population ( post-transplantation, steroid use \\> 5 mg per day, malignancy, HIV, on chemotherapy).\n* Population with history of thrombocytopenia ( ITP, aplastic anemia, drug induced)\n* History of thrombocytosis ( idiopathic thrombocytosis, post-splenectomy)\n* History of platelet transfusion one week before admission.\n* Bone marrow transplanted population .\n* Chronic liver and kidney disease.\n* Von-Willebrand disease.\n* Patients on antiplatelet therapy ( Aspirin, clopidogrel).\n* Thrombocytopenic population ( ITP, TTP,HELLP) .\n* Myelodysplastic or proliferative patients.\n* Blood dyscarsiasis\n* Obestetric parturients."}, "identificationModule"=>{"nctId"=>"NCT06612307", "briefTitle"=>"Sensitivity and Specificity of Leucocytes Subpopulation Versus Platelet Indices in Prediction of Clinical Outcome for Candidates With Sepsis. A Bi-centric Observational Clinical Trial", "organization"=>{"class"=>"OTHER", "fullName"=>"Minia University"}, "officialTitle"=>"Sensitivity and Specificity of Leucocytes Subpopulation Versus Platelet Indices in Prediction of Clinical Outcome for Candidates With Sepsis. A Bi-centric Clinical Trial", "orgStudyIdInfo"=>{"id"=>"Anet 19-2"}}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Minia University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Ass professor anesthesia and pain", "investigatorFullName"=>"Mina Maher", "investigatorAffiliation"=>"Minia University"}}}}
