[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bluejay Diagnostics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100625665","multicenter-symphony-il-6-monitoring-sepsis-ed-pilot-study-100625665",false,"NCT07425587","Multicenter Symphony™ IL-6 Monitoring Sepsis ED Pilot Study","SYMON III","Inclusion Criteria:\n\n* Adult patients (≥22 years of age)\n* Intent to admit to hospital or admitted to the hospital via the emergency department\n* At least 0.6 mL plasma drawn (optimal 1 mL) and available for collection (or is anticipated to be able to be drawn and available) within 12 hours of (i.e., up to 12 hours after) presentation to the emergency department. For Cohort 1, Criterion #1 criteria should be met within 3 hours of sample collection (fresh or remnant).\n* Meets criteria for at least one of the 3 cohorts (patients may be included in more than one cohort) within 12 hours of emergency department presentation:\n\n  1\\. Cohort 1 (Systemic inflammatory response or culture ordered):\n* Criterion #1 (2 of below within 3 hours of sample collection, of which 1 is at least (A) or (B))\n* A) body temperature \\>38C or \\\u003C36C,\n* B) HR\\>90 beats\u002Fmin,\n* C) respiratory rate \\>20 breaths\u002Fmin, or\n* D) white blood cell count \\> 12K or \\\u003C4K\u002Fmicroliters or over 10% immature forms or bands) OR:\n* Criterion #2 (order for culture of a body fluid (e.g., blood, urine, sputum))\n\n  2\\. Cohort 2 (Treatment for suspected infection initiated):\n* Meets criteria for Cohort 1 and antimicrobials (antibiotics or antivirals) ordered.\n\n  3\\. Cohort 3 (Confirmed or strong evidence of infection):\n* Meets criteria for Cohorts 1 and 2, AND 1 or more of the following criteria:\n* Temp \\>101F (38.3C)\n* pneumonia by x-ray or CT,\n* Urinalysis with WBC\\>10\u002FHPF;\n* Intraabdominal-pelvis infection by CT, U\u002FS, or MRI\n* Skin \u002F soft tissue infection by clinical exam\n* Evidence of meningitis on LP;\n* Positive microbiological culture (cultures drawn within 3 days of presentation)\n* Suspected line infection (e.g. redness or pus around the line)\n\nExclusion Criteria:\n\n* Prisoners or imprisonment at time of enrollment\n* Pregnant\n* Prior enrollment into this study\n* Informed consent as approved by IRB is unable to be obtained.\n* Environmental exposure (e.g., heat exposure)","ALL","22 Years",{"count":19,"type":20},450,"ESTIMATED","OBSERVATIONAL","The primary objective of this study is to establish an IL-6 concentration cutoff that predicts sepsis or septic shock (according to the Third International Consensus Definitions (Sepsis-3 criteria)) in patients who are admitted or are intended to be admitted to the hospital from the emergency department with suspected infection.",[24],"Sepsis, Septic Shock",[26,27,28,29,30,31,32,33,34,35,36,37],"Interleukin-6","IL-6","Risk Stratification","Infections","Toxima","Systemic Inflammatory Response Syndrome","Inflammation","Sepsis","Septic Shock","Shock","Pathologic Process","Emergency Department","RECRUITING","2026-07-01",{"date":41,"type":42},"2026-07-02","ACTUAL",{"date":44,"type":42},"2026-05-04",{"date":46,"type":20},"2026-12-30",{"name":48,"class":49},"Bluejay Diagnostics, Inc.","INDUSTRY",5,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":50},"100566416","multicenter-symphony-il-6-monitoring-sepsis-icu-validation-study-100566416","NCT06654895","Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study","SYMON II","Inclusion Criteria:\n\n* Adult patients (≥22 years of age)\n* Diagnosis of sepsis or septic shock based on: the Third International Consensus Definitions (Sepsis-3 criteria) defined as at least one of the following criteria as determined by a treating physician or study physician investigator.\n\n  * Sepsis: suspected or documented infection (i.e., use or intent to use antibiotics as an indicator) and organ dysfunction defined by a Sequential Organ Failure Assessment (SOFA) score ≥2\n  * Septic shock: sepsis requiring vasopressors and serum lactate levels \\>2 mmol\u002FL (18 mg\u002FdL)\n* Admitted or intended to be admitted to the ICU\n* At least 3 mL plasma drawn and available for collection (or is anticipated to be able to be drawn and available) within 24 hours of (i.e., up to 24 hours after) the earliest diagnosis of sepsis or septic shock.\n\nExclusion Criteria:\n\n* Prisoners or imprisonment at time of enrollment\n* Prior enrollment into this study\n* Informed consent as approved by IRB is unable to be obtained.",{"count":59,"type":20},700,"The primary objective of this study is to validate a pre-defined IL-6 concentration cutoff that predicts 28-day mortality in patients who are admitted or are intended to be admitted to the ICU diagnosed with sepsis or septic shock.",[24],[26,27,28,29,30,31,32,63,33,34,35],"Pathologic Processes","2026-02-02",{"date":66,"type":42},"2026-02-03",{"date":68,"type":42},"2024-11-12",{"date":70,"type":20},"2026-08-30",{"name":48,"class":49},""]