[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dohern Kym\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100602673","evaluating-the-accuracy-of-multiple-blood-tests-to-diagnose-sepsis-in-adult-burn-patients-100602673",false,"NCT07126574","Evaluating the Accuracy of Multiple Blood Tests to Diagnose Sepsis in Adult Burn Patients","Research Protocol for Evaluating the Diagnostic Utility of SAA, Procalcitonin, Presepsin, CRP, and Routine Blood Biomarkers in Adult Burn Patients With Sepsis in the Intensive Care Unit","BioBurnSepsis","Inclusion Criteria:\n\n* Age 18 years or older.\n* Admission to the Burn Intensive Care Unit (BICU) with a burn injury covering ≥10% of the Total Body Surface Area (TBSA).\n* Undergoing a blood culture due to clinical suspicion of sepsis (e.g., fever, abnormal white blood cell count, hemodynamic instability) during the ICU stay.\n* The participant or their legally authorized representative has provided written informed consent.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Pre-existing immunological conditions that, in the investigator's judgment, could interfere with biomarker interpretation (e.g., long-term use of immunosuppressants, congenital immunodeficiency).\n* Inability to participate at the time of study-related blood collection due to initial emergency surgery, major trauma, or significant hemorrhage.\n* Any other condition for which the principal investigator deems participation to be inappropriate or unsafe for the patient.","ALL","18 Years",{"count":20,"type":21},165,"ESTIMATED","1 Year","OBSERVATIONAL","This prospective diagnostic accuracy study evaluates the performance of presepsin and C-reactive protein (CRP) as early biomarkers for suspected sepsis in adult burn patients. From January 2021 to December 2022, 370 patients with ≥20% total body surface area burns admitted to the Burn Intensive Care Unit at Hallym University Hangang Sacred Heart Hospital were screened; 221 met inclusion criteria. At each clinical suspicion of sepsis (≥2 SIRS criteria), venous blood was drawn for simultaneous measurement of presepsin (via chemiluminescent immunoassay) and CRP (via immunoturbidimetric assay). Diagnostic accuracy will be quantified by sensitivity, specificity, positive\u002Fnegative predictive values, and area under the ROC curve. The goal is to determine whether presepsin outperforms CRP for early sepsis detection in severe burn patients.",[26,27],"Sepsis - to Reduce Mortality in the Intensive Care Unit","Burns Involving 20% or More of Body Surface",[29,30,31,32],"presepsin","diagnostic accuracy","biomarker evaluation","Serum Amyloid A","NOT_YET_RECRUITING","2025-08-10",{"date":36,"type":37},"2025-08-17","ACTUAL",{"date":39,"type":21},"2025-08-15",{"date":41,"type":21},"2026-10-31",{"name":43,"class":44},"Dohern Kym","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":55,"studyType":23,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100597597","presepsin-diagnostic-performance-in-severe-burn-sepsis-100597597","NCT07060560","Presepsin Diagnostic Performance in Severe Burn Sepsis","Prospective Observational Study to Evaluate the Diagnostic Accuracy of Presepsin for Sepsis in Severe Burn Patients","PSEP-BURNS","Inclusion Criteria:\n\n* Adults aged ≥ 18 years admitted to Hangang Sacred Heart Hospital Burn ICU with total body surface area (TBSA) ≥ 20 %\n* Clinical suspicion of sepsis prompting blood culture and biomarker sampling\n* Ability to understand the study and provide written informed consent (or via legally authorized representative)\n\nExclusion Criteria:\n\n* Inability to undergo research blood draw due to emergent surgery or major trauma at sampling time\n* Chronic immunosuppressive conditions (e.g., long-term high-dose steroids, organ transplant, congenital immunodeficiency)\n* Pregnant women or those with significant psychiatric conditions precluding consent\n* Any other medical or safety concerns deemed inappropriate by the investigator",{"count":54,"type":21},138,"4 Days","This study enrolls approximately 270 adult patients with severe burns covering at least 20% of total body surface area to evaluate how well the blood biomarker presepsin diagnoses sepsis early in this high-risk population. Sepsis-a life-threatening condition caused by an exaggerated immune response to infection-is particularly urgent to detect promptly in burn patients. Participants will undergo blood tests for presepsin at predefined time points, and these results will be compared to C-reactive protein (CRP), procalcitonin (PCT) levels, Sepsis-3 clinical criteria, and blood culture findings. The primary goal is to measure presepsin's sensitivity and specificity for sepsis detection, thereby determining its diagnostic accuracy. Findings from this study may enable faster sepsis treatment in severe burn patients and improve clinical outcomes.",[58,59],"Sepsis","Burns","RECRUITING","2025-08-06",{"date":63,"type":37},"2025-08-11",{"date":65,"type":37},"2025-05-01",{"date":67,"type":21},"2026-05-01",{"name":43,"class":44},1,""]