[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05304728":3,"trial-entities:NCT05304728":141,"trial-summary:NCT05304728":145},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":29,"secondary_outcomes":33,"sex":44,"minimum_age":45,"maximum_age":46,"healthy_volunteers":23,"eligibility_criteria":47,"std_ages":54,"locations":57,"central_contacts":133,"overall_officials":134,"references":139,"see_also_links":140},"NCT05304728","2.7.2-1","Sepsis Clinical Decision Support [CDS] Master Enrollment Study Protocol","Sepsis Onset Warning System [SOWS] Master Enrollment Study Protocol","ENROLLING_BY_INVITATION","2026-12-31","2024-06","2024-06-21","2021-02-15","Beckman Coulter, Inc.","INDUSTRY",false,"This protocol will collect real-world data retrospectively from the electronic health record (EHR) as data obtained from the delivery of routine medical care to develop a machine learning (ML)-based Clinical Decision Support (CDS) system for severe sepsis prediction and detection.","The purpose of this study is to gather data for the clinical development of the Sepsis Onset Warning System (SOWS) Software as Medical Device (SaMD) product to support a De Novo FDA submission and commercialization in the United States. Product development of SOWS is funded in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority.\n\nData will be obtained from passive prospective collection of patient encounter data throughout the duration of the planned study to support the product development life cycle activities associated with developing the Sepsis Onset Warning System (SOWS) for severe sepsis risk detection. Inputs from patient health records in combination with proprietary hematology parameters developed by Beckman Coulter, such as Monocyte Distribution Width (MDW), will be used. The SOWS tool will look to use clinical measurements which are commonly and reliably available in the EHR as structured data elements, such as heart rate, temperature, blood pressure, and laboratory results and account for changes in these values over time.",[19,20],"Severe Sepsis","Severe Sepsis Without Septic Shock",[],"OBSERVATIONAL",null,[],{"count":26,"type":27},40000,"ESTIMATED",[],[30],{"measure":19,"description":31,"timeFrame":32},"Identify patients having Severe Sepsis with the use of electronic health data","Within 6 hours from presentation to the emergency department",[34,38,41],{"measure":35,"description":36,"timeFrame":37},"Mortality","Hospital mortality at hospital for Severe Sepsis patients identified by algorithm using electronic health data as potential benefits for increased early detection of risk of severe sepsis","Within 6hours from presentation to the emergency department",{"measure":39,"description":40,"timeFrame":37},"Length of Stay","Determine length of stay at hospital for Severe Sepsis patients identified by algorithm using electronic health data as potential benefits for increased early detection of risk of severe sepsis",{"measure":42,"description":43,"timeFrame":37},"Re-admission Rates","Determine potential reduction of hospital readmission rates for Severe Sepsis patients identified by algorithm using electronic health data as potential benefits for increased early detection of risk of severe sepsis","ALL","18 Years","89 Years",{"inclusion":48,"exclusion":51,"raw_text":53},[49,50],"All races, ages and ethnicities","All patients admitted to the hospital or presenting to the Emergency Department",[52],"Patients not presenting to a hospital setting (e.g. urgent care, outpatient clinic excluded).","Inclusion Criteria:\n\n* All races, ages and ethnicities\n* All patients admitted to the hospital or presenting to the Emergency Department\n\nExclusion Criteria:\n\n* Patients not presenting to a hospital setting (e.g. urgent care, outpatient clinic excluded).",[55,56],"ADULT","OLDER_ADULT",[58,67,75,83,91,95,103,111,119,126],{"facility":59,"city":60,"state":61,"zip":62,"country":63,"geoPoint":64},"University of California, Irvine","Irvine","California","92697","United States",{"lat":65,"lon":66},33.66946,-117.82311,{"facility":68,"city":69,"state":70,"zip":71,"country":63,"geoPoint":72},"Augusta University Medical School","Augusta","Georgia","30912",{"lat":73,"lon":74},33.47097,-81.97484,{"facility":76,"city":77,"state":78,"zip":79,"country":63,"geoPoint":80},"Indiana University Health","Indianapolis","Indiana","46202-5200",{"lat":81,"lon":82},39.76838,-86.15804,{"facility":84,"city":85,"state":86,"zip":87,"country":63,"geoPoint":88},"University Health\u002F Truman Medical Center","Kansas City","Missouri","64108",{"lat":89,"lon":90},39.09973,-94.57857,{"facility":92,"city":85,"state":86,"zip":93,"country":63,"geoPoint":94},"University of Kansas Medical Center","66103",{"lat":89,"lon":90},{"facility":96,"city":97,"state":98,"zip":99,"country":63,"geoPoint":100},"Hackensack University Medical Center","Hackensack","New Jersey","07601",{"lat":101,"lon":102},40.88593,-74.04347,{"facility":104,"city":105,"state":106,"zip":107,"country":63,"geoPoint":108},"WakeMed Health","Raleigh","North Carolina","27610",{"lat":109,"lon":110},35.7721,-78.63861,{"facility":112,"city":113,"state":114,"zip":115,"country":63,"geoPoint":116},"University of Cininnati","Cincinnati","Ohio","45221",{"lat":117,"lon":118},39.12711,-84.51439,{"facility":120,"city":121,"state":114,"zip":122,"country":63,"geoPoint":123},"MetroHealth Systems","Cleveland","44109",{"lat":124,"lon":125},41.4995,-81.69541,{"facility":127,"city":128,"state":114,"zip":129,"country":63,"geoPoint":130},"The Ohio State University","Columbus","43210",{"lat":131,"lon":132},39.96118,-82.99879,[],[135],{"name":136,"affiliation":137,"role":138},"Elliott Crouser, MD","Ohio State University","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":142,"biomarkers":144},[143,19],"Sepsis without septic shock",[],{"nct_id":4,"found":15,"summary":23,"prompt_version":23}]