NCT07126574Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 165 (estimated)
- First submitted
- 6 Aug 2025
- Start date
- 15 Aug 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Dohern Kym
- NCT number
- NCT07126574
What you commit to
- Study type: Observational
- Planned participants: 165
- From 15 Aug 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hangang Sacred Heart Hospital, Hallym University Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.