[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602673":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":12,"collaborators":10,"id":16,"slug":17,"hasResults":18,"nctId":19,"briefTitle":20,"officialTitle":21,"acronym":22,"eligibilityCriteria":23,"healthyVolunteers":18,"sex":24,"minAge":25,"maxAge":10,"enrollmentInfo":26,"targetDuration":29,"studyType":30,"phases":10,"briefSummary":31,"conditions":32,"keywords":35,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":10},{"fullName":5,"class":6},"Hangang Sacred Heart Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Burn patients with suspected sepsis",null,"Adults ≥18 years with ≥20% TBSA burns admitted to the Burn Intensive Care Unit who developed clinically suspected sepsis (≥2 SIRS criteria)",{"type":13,"investigatorFullName":14,"investigatorTitle":15,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Dohern Kym","Attending Physician, Burn Intensive Care Unit","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":27,"type":28},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.",[33,34],"Sepsis - to Reduce Mortality in the Intensive Care Unit","Burns Involving 20% or More of Body Surface",[36,37,38,39],"presepsin","diagnostic accuracy","biomarker evaluation","Serum Amyloid A","NOT_YET_RECRUITING","2025-08-10",{"date":43,"type":44},"2025-08-17","ACTUAL",{"date":46,"type":28},"2025-08-15",{"date":48,"type":28},"2026-10-31",{"name":14,"class":6}]