SepsisPSEP-BURNSNCT07060560
Presepsin Diagnostic Performance in Severe Burn Sepsis
An observational study of Sepsis and Burns, run by Dohern Kym at 1 site in South Korea.
Trial summary
This study enrolls approximately 270 adult patients with severe burns covering at least 20% of total body surface area to evaluate how well the blood biomarker presepsin diagnoses sepsis early in this high-risk population. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 138 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2025to 31 Mar 2027
- How long will I take part?
- 4 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A prospective cohort of adult (≥ 18 years) patients with severe burns (TBSA ≥ 20 %) admitted to the Burn Intensive Care Unit at Hangang Sacred Heart Hospital
Who may be able to join
- Adults aged ≥ 18 years admitted to Hangang Sacred Heart Hospital Burn ICU with total body surface area (TBSA) ≥ 20 %
- Clinical suspicion of sepsis prompting blood culture and biomarker sampling
- Ability to understand the study and provide written informed consent (or via legally authorized representative)
Who cannot join
- Inability to undergo research blood draw due to emergent surgery or major trauma at sampling time
- Chronic immunosuppressive conditions (e.g., long-term high-dose steroids, organ transplant, congenital immunodeficiency)
- Pregnant women or those with significant psychiatric conditions precluding consent
- Any other medical or safety concerns deemed inappropriate by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Hangang Sacred Heart Hospital, Hallym University Medical Center
Seoul, Seoul, 07981
Ra Gyeom Seong, 01094157154, dohern@hallym.or.kr
Dohern
About this study
Official title: Prospective Observational Study to Evaluate the Diagnostic Accuracy of Presepsin for Sepsis in Severe Burn Patients
This study enrolls approximately 270 adult patients with severe burns covering at least 20% of total body surface area to evaluate how well the blood biomarker presepsin diagnoses sepsis early in this high-risk population. Sepsis-a life-threatening condition caused by an exaggerated immune response to infection-is particularly urgent to detect promptly in burn patients. Participants will undergo blood tests for presepsin at predefined time points, and these results will be compared to C-reactive protein (CRP), procalcitonin (PCT) levels, Sepsis-3 clinical criteria, and blood culture findings. The primary goal is to measure presepsin's sensitivity and specificity for sepsis detection, thereby determining its diagnostic accuracy. Findings from this study may enable faster sepsis treatment in severe burn patients and improve clinical outcomes.
- Medical subject headings
- Sepsis, Burns
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic sensitivity and specificity of presepsin for sepsis in severe burn patients
The proportion of true-positive and true-negative presepsin results for diagnosing sepsis using Sepsis-3 clinical criteria and positive blood culture as the reference standard.
Measured: Up to 2 hours after initial clinical suspicion of sepsis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
- Target duration
- 4 Days
Sponsor and investigators
- Lead sponsor
- Dohern Kym
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dohern Kym, Hangang Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060560
- Sponsor's protocol ID
- 2025-009
- Acronym
- PSEP-BURNS
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study to Evaluate the Diagnostic Accuracy of Presepsin for Sepsis in Severe Burn Patients
- ClinicalTrials.gov ID
- NCT07060560
- Acronym / sponsor ID
- PSEP-BURNS / 2025-009
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Dohern KymUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study enrolls approximately 270 adult patients with severe burns covering at least 20% of total body surface area to evaluate how well the blood biomarker presepsin diagnoses sepsis early in this high-risk population. Sepsis-a life-threatening condition caused by an exaggerated immune response to infection-is particularly urgent to detect promptly in burn patients. Participants will undergo blood tests for presepsin at predefined time points, and these results will be compared to C-reactive protein (CRP), procalcitonin (PCT) levels, Sepsis-3 clinical criteria, and blood culture findings. The primary goal is to measure presepsin's sensitivity and specificity for sepsis detection, thereby determining its diagnostic accuracy. Findings from this study may enable faster sepsis treatment in severe burn patients and improve clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A prospective cohort of adult (≥ 18 years) patients with severe burns (TBSA ≥ 20 %) admitted to the Burn Intensive Care Unit at Hangang Sacred Heart Hospital
Key inclusion criteria (3 listed)
- Adults aged ≥ 18 years admitted to Hangang Sacred Heart Hospital Burn ICU with total body surface area (TBSA) ≥ 20 %
- Clinical suspicion of sepsis prompting blood culture and biomarker sampling
- Ability to understand the study and provide written informed consent (or via legally authorized representative)
Key exclusion criteria (4 listed)
- Inability to undergo research blood draw due to emergent surgery or major trauma at sampling time
- Chronic immunosuppressive conditions (e.g., long-term high-dose steroids, organ transplant, congenital immunodeficiency)
- Pregnant women or those with significant psychiatric conditions precluding consent
- Any other medical or safety concerns deemed inappropriate by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic sensitivity and specificity of presepsin for sepsis in severe burn patients
Time frame: Up to 2 hours after initial clinical suspicion of sepsis.
The proportion of true-positive and true-negative presepsin results for diagnosing sepsis using Sepsis-3 clinical criteria and positive blood culture as the reference standard.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hangang Sacred Heart Hospital, Hallym University Medical Center
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Burns, run by Dohern Kym at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic sensitivity and specificity of presepsin for sepsis in severe burn patients (time frame: Up to 2 hours after initial clinical suspicion of sepsis.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.