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Enrolling By Invitation
NCT07126574
Evaluating the Accuracy of Multiple Blood Tests to Diagnose Sepsis in Adult Burn Patients
Conditions: Sepsis - to Reduce Mortality in the Intensive Care Unit, Burns Involving 20% or More of Body Surface
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 165
Sponsor: Dohern Kym
Location: Hangang Sacred Heart Hospital, Hallym University Medical Center Seoul
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.
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or older.
* Admission to the Burn Intensive Care Unit (BICU) with a burn injury covering ≥10% of the Total Body Surface Area (TBSA).
* Undergoing a blood culture due to clinical suspicion of sepsis (e.g., fever, abnormal white blood cell count, hemodynamic instability) during the ICU stay.
* The participant or their legally authorized representative has provided written informed consent.
Exclusion Criteria:
* Pregnancy.
* Pre-existing immunological conditions that, in the investigator's judgment, could interfere with biomarker interpretation (e.g., long-term use of immunosuppressants, congenital immunodeficiency).
* Inability to participate at the time of study-related blood collection due to initial emergency surgery, major trauma, or significant hemorrhage.
* Any other condition for which the principal investigator deems participation to be inappropriate or unsafe for the patient.
Source: ClinicalTrials.gov (NCT07126574). StuddyBuddy aggregates publicly available trial information.