Evaluating the Accuracy of Multiple Blood Tests to Diagnose Sepsis in Adult Burn Patients

NCT07126574 | Not Yet Recruiting

• 1 other identifier: 2025-020
• Study Type: observational
• Target: 165
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis - to Reduce Mortality in the Intensive Care Unit; Burns Involving 20% or More of Body Surface

Keywords

presepsin; diagnostic accuracy; biomarker evaluation; Serum Amyloid A

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of presepsin for early sepsis detection

  Sensitivity and specificity of presepsin (measured by chemiluminescent immunoassay on PATHFAST analyzer) for diagnosing clinically suspected sepsis (≥2 SIRS criteria) in adult burn patients.

  At the time of clinical suspicion of sepsis (Day 0), and daily for the following 7 days (Day 1 through Day 7).

Secondary Outcomes (1)

• Area under the ROC curve (AUC) for presepsin versus CRP

  Through study completion, an average of 1.5 years.

Study Arms (1)

Burn patients with suspected sepsis

Adults ≥18 years with ≥20% TBSA burns admitted to the Burn Intensive Care Unit who developed clinically suspected sepsis (≥2 SIRS criteria)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years) with severe thermal burns (TBSA ≥20%) admitted to a single-center BICU who developed clinically suspected sepsis (≥2 SIRS criteria) during the enrollment period; all participants underwent standardized blood sampling for presepsin and CRP assays

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dohern Kym: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician, Burn Intensive Care Unit

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 17, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08