[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100413922":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":21,"armGroups":22,"interventions":17,"overallOfficials":26,"centralContacts":30,"locations":35,"responsibleParty":58,"collaborators":17,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":17,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":17,"enrollmentInfo":69,"targetDuration":17,"studyType":72,"phases":17,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":37,"whyStopped":17,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University of Miami","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Number of participants at each endotoxin activity level after surgery.","The endotoxin activity level assessed from blood samples will be categorized as low (\\\u003C0.40), intermediate (0.40-0.59) or high (≥0.60) endotoxin activity level. Analysis will be done via Endotoxin Activity Assay (EAA).","Day 1 (within 30 minutes postoperative)",{"measure":14,"description":15,"timeFrame":16},"Corelation of endotoxin activity level with post-operative infectious complication","infectious complications include fever, and signs and symptoms of systemic inflammatory response syndrome as evaluated by treating physician.","up to 24 hours",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"CASE_ONLY","PROSPECTIVE","Patients scheduled for PCNL as surgical treatment for their kidney stones at Jackson and the University of Miami Hospitals.",[23],{"label":24,"type":17,"description":25,"interventionNames":17},"endotoxin study group","Patients scheduled for Percutaneous Nephrolithotomy (PCNL) as surgical treatment for their kidney stones will be evaluated for postoperative endotoxin levels as a risk marker for sepsis.",[27],{"name":28,"affiliation":5,"role":29},"Hemendra N Shah","PRINCIPAL_INVESTIGATOR",[31],{"name":28,"role":32,"phone":33,"phoneExt":17,"email":34},"CONTACT","3052433246","hns35@miami.edu",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Miami","Florida","33136","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-80.19366,25.77427,{"lat":47,"lon":46},[50,52,55,56],{"name":51,"role":32,"phone":33,"phoneExt":17,"email":34},"Hemendra N Shah, MD",{"name":17,"role":32,"phone":17,"phoneExt":53,"email":54},"shah","drhemendrashah@yahoo.co.in",{"name":51,"role":29,"phone":17,"phoneExt":17,"email":17},{"name":57,"role":29,"phone":17,"phoneExt":17,"email":17},"Robert Marcovich, MD",{"type":29,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Hemendra Shah","Associate Professor of clinical Urology","100413922","serum-endotoxin-assay-to-predict-the-development-of-postoperative-infectious-complications-and-systemic-inflammatory-response-following-percutaneous-nephrolithotomy-100413922",false,"NCT04669886","Serum Endotoxin Assay to Predict the Development of Postoperative Infectious Complications and Systemic Inflammatory Response Following Percutaneous Nephrolithotomy.","Inclusion Criteria:\n\n* Adults that is able to consent (≥ 18 years of age)\n* Scheduled to undergo PCNL at Uhealth tower and Jackson Memorial Hospitals\n* not currently immunosuppressed \\[White blood count (WBC) \\>= 2, not on immunosuppressive medications\\]\n\nExclusion Criteria:\n\n* unable to consent and \\\u003C 18 years of age\n* currently immunosuppressed (WBC \\\u003C 2, not on immunosuppressive medications)","ALL","18 Years",{"count":70,"type":71},150,"ESTIMATED","OBSERVATIONAL","The aim of the study is to establish an infectious risk stratification system based on pre-and post-operative blood endotoxin profile.",[75,76],"Nephrolithiasis","Urosepsis",[78,79,80,81,82],"endotoxin","fever","infectious complications","endourology","percutaneous nephrolithotomy","2026-08-25",{"date":85,"type":86},"2026-08-27","ACTUAL",{"date":88,"type":86},"2023-11-01",{"date":90,"type":71},"2027-12-30",{"name":5,"class":6},1]