[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569049":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":10,"centralContacts":32,"locations":38,"responsibleParty":59,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":10,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":10,"enrollmentInfo":74,"targetDuration":77,"studyType":78,"phases":10,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Ningbo Medical Center Lihuili Hospital","OTHER_GOV",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy control group",null,"Individuals who are physically healthy with no underlying diseases and have not been hospitalized within the past two years. Recruitment for healthy volunteers will be conducted through notices and online media.",[13],"Other: Blood fluorescence metabolite analysis",{"label":15,"type":10,"description":16,"interventionNames":17},"Infected Non-Sepsis Patient Group","Patients with infections and a SOFA score of 1 will be screened and confirmed by a physician to meet the inclusion criteria. After obtaining informed consent, a nurse will collect a 4 cc blood sample within 24 hours of qualification. Within 7 days of ICU admission, physicians will assess whether patients with non-sepsis infections progress to sepsis. If so, these patients will be categorized into the sepsis patient group. One week post-discharge and on the 28th day post-diagnosis, a nurse will follow up to inquire about their health status.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Vasopressorin treated sepsis group","Patients with confirmed infections, having qSOFA ≥ 2 and SOFA ≥ 2, accepted with vasopressor therapy, will be screened and confirmed by a physician to meet the inclusion criteria. After physician confirmation that the inclusion criteria are met, patients will be informed and asked to sign an informed consent form. Blood samples (4 cc) will be collected within 24 hours before and after hospitalization entry and within 24h after transferred out of the ICU.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"No vasopressor theapy sepsis group","Group\u002FCohort Description: Patients with confirmed infections, having qSOFA ≥ 2 and SOFA ≥ 2, without vasopressor therapy, will be screened and confirmed by a physician to meet the inclusion criteria. After physician confirmation that the inclusion criteria are met, patients will be informed and asked to sign an informed consent form. Blood samples (4 cc) will be collected within 24 hours before and after hospitalization entry.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"OTHER","Blood fluorescence metabolite analysis","This is an observational study and does not involve intervention. In both the early and late stages of sepsis, a significant increase in inflammatory free radicals changes the optical properties of the patient\\'s blood, distinguishing it from that of healthy individuals. To explore this phenomenon, 4 cc of fasting blood is drawn from patients who pass our screening criteria. This sample is then centrifuged in accordance with our detailed standard operating procedures to ready it for analysis. Subsequently, the fluorescence intensity of the blood is measured quantitatively using a precisely calibrated blood fluorometer, which is specifically designed to detect subtle variations indicative of both early and late sepsis. This entire process is executed under stringent quality control protocols to ensure the reliability and accuracy of the results, which are pivotal for the timely diagnosis and intervention in septic patients.",[9,15,23,19],[33],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Fei Guo, Dr.","CONTACT","86 13646607121","lhlguofei@nbu.edu.cn",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Ningbo Institute of Innovation for Combined Medicine and Engineering (NIIME), Ningbo Medical Center Lihuili Hospital, Ningbo University","RECRUITING","Ningbo","Zhejiang","315010","China","CN",{"type":48,"coordinates":49},"Point",[50,51],121.54945,29.87819,{"lat":51,"lon":50},[54,57],{"name":5,"role":35,"phone":55,"phoneExt":10,"email":56},"008687018701","lhl2290@mail.nbptt.zj.cn",{"name":34,"role":58,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[62],{"name":63,"class":28},"University of Macau","100569049","detection-of-sepsis-occurrence-by-using-blood-fluorescence-100569049",false,"NCT06689189","Detection of Sepsis Occurrence by Using Blood Fluorescence","Metabolite Fluorescence Analysis in Critically Ill Patients' Blood and the Development of a Blood Fluorescence Analytical Platform","Inclusion Criteria:\n\n1. Healthy control group: Individuals who are physically healthy with no underlying diseases and have not been hospitalized within the past two years. Recruitment for healthy volunteers will be conducted through notices and online media.\n2. Sepsis Experimental Group: Patients with confirmed infections, having qSOFA ≥ 2 and SOFA ≥ 2, will be screened and confirmed by a physician to meet the inclusion criteria.\n3. Non-septic Severe Control Group: Patients with suspected or confirmed infections, having a SOFA score of 1, will be screened and confirmed by a physician to meet the inclusion criteria.\n\nExclusion Criteria: minors, pregnant, individuals with mental illnesses, and other vulnerable groups.",true,"ALL","18 Years",{"count":75,"type":76},800,"ESTIMATED","1 Month","OBSERVATIONAL","This study adopted a case-control study method to explore a reagent-free, highly sensitive, and frequently screened blood fluorescence metabolite analyzer for sepsis, which can detect the emergence of inflammatory free radicals before organ damage and shorten the diagnosis time of sepsis.",[81,82],"Sepsis","Organ Damage",[81,84,85,86,87,88],"Organ damage","Blood metabolite fluorescence","Machine learning","Deep learning","Fluorescence spectrum analytical platform","2024-11-12",{"date":91,"type":92},"2024-11-14","ACTUAL",{"date":94,"type":92},"2024-01-24",{"date":96,"type":76},"2027-10-01",{"name":5,"class":6},1]