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Life sciences · Observational Study
ClinicalTrials.gov · October 5, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07126574). This is a study registration, not published results. Lead sponsor: Dohern Kym. Recruitment status: ENROLLING_BY_INVITATION. Study type: OBSERVATIONAL. Enrollment: 165 participants (ESTIMATED). Conditions: Sepsis - to Reduce Mortality in the Intensive Care Unit, Burns Involving 20% or More of Body Surface. Primary outcome measures: Diagnostic accuracy of presepsin for early sepsis detection , At the time of clinical suspicion of sepsis (Day 0), and daily for the following 7 days (Day 1 through Day 7).. Brief summary: 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/negative 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.