SepsisNCT07866521
Sepsis Biomarker Monitoring in Burn Patients
A study testing PSP Monitoring in people with Sepsis and Burn, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if using pancreatic stone protein (PSP) test results helps doctors find and treat sepsis earlier in adults with serious burn injuries. The study will also look at whether using PSP is safe and practical in the burn intensive care unit. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Sepsis, Burn, Inflammation
- What is being tested?
- PSP Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Aug 2028
- Phase
- Interventional
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 - 89 years
- Diagnosed with Burn injury of any mechanism
- Admitted to the Burn Surgical Team at UMC Hospital with a critical condition/ICU status. Critically ill burns overflowed to TSICU may still be enrolled.
- Expected ICU stay > 48 hours
- Subject will be approached during the first 24 hours after burn injury with an invitation to participate
Who cannot join
- Inability to approach/consent within 24 hours after the time of injury
- Existing sepsis requiring antibiotics within 24 hours of admission
- Prisoners
- Incomplete chart data
- Acute or chronic pancreatitis
- Abdominal pathologies
Show all 10Show fewer
- Advanced renal failure (acute or chronic)
- Pre-existing multiple organ failure
- Limited life span, expected death within 3 days of admission due to the severity of injury
- Lower acuity burns admitted to the burn stepdown.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Texas Tech University Health Sciences Center/ University Medical Center Lubbock
Lubbock, Texas, 79430
Lane Young, BA, CCRC, +1 806-743-4217, lane.young@ttuhsc.edu
Chris Scott, MSN, RNC-P, CCRC, CA/CP, SANE, +1 806-743-4217, chris.scott@ttuhsc.edu
About this study
Official title: A Randomized Trial of Blinded vs Unblinded Sepsis Biomarker Monitoring in Burn Patients
The goal of this clinical trial is to learn if using pancreatic stone protein (PSP) test results helps doctors find and treat sepsis earlier in adults with serious burn injuries. The study will also look at whether using PSP is safe and practical in the burn intensive care unit. The main questions it aims to answer are:
- Does seeing PSP test results help doctors start the right antibiotics sooner?
- Does using PSP reduce unnecessary antibiotic use?
- Does using PSP improve recovery and other health outcomes?
Read more
Researchers will compare two groups of patients. One group will receive standard care, and their PSP test results will be hidden from their care team. The other group will receive standard care, but their care team will be able to see the PSP test results and use them to help make treatment decisions.
Participants will:
- Be randomly assigned to one of the two study groups.
- Have a small blood sample taken within 24 hours after being admitted to the burn ICU and then once each weekday while they are in the ICU.
- Receive the usual care for burn injuries and sepsis throughout the study.
Read the detailed description
Burn patients are at high risk of developing sepsis, a life-threatening response to infection that can lead to organ failure and death if not recognized and treated quickly. Early diagnosis is especially difficult in this population because burn injuries and repeated surgical procedures cause inflammation that closely resembles the body's response to infection. Common laboratory tests used to detect sepsis, such as C-reactive protein (CRP) and procalcitonin (PCT), often increase in response to both infection and noninfectious inflammation, making it difficult for clinicians to distinguish between the two.
Pancreatic stone protein (PSP) is an emerging biomarker that has shown promise for the early detection of sepsis in critically ill patients. Previous observational studies suggest that PSP is less influenced by sterile inflammation than conventional biomarkers and may increase before patients develop overt clinical signs of sepsis. However, it remains unclear whether providing PSP results to clinicians changes clinical decision-making or improves patient outcomes. Most published studies have evaluated the diagnostic performance of PSP rather than its impact on patient management.
This study is a prospective, randomized clinical utility trial designed to evaluate whether integrating serial PSP measurements into routine burn intensive care improves sepsis management. Participants will be randomly assigned to receive either standard care with PSP results concealed from the treating clinical team or standard care with PSP results available to clinicians in real time. In the intervention group, PSP values will be interpreted using a predefined clinical algorithm in conjunction with clinical assessment. Clinicians will retain full authority over patient management and may override algorithm recommendations whenever clinically appropriate.
The study is designed to determine whether access to PSP results improves the timeliness of sepsis recognition while reducing unnecessary antibiotic exposure and preserving patient safety. In addition to evaluating clinical outcomes, the study will assess the feasibility of incorporating routine PSP monitoring into burn intensive care workflows.
- Conditions
- Sepsis, Burn, Inflammation, Burn Infection
- Being tested
- PSP Monitoring
- Keywords
- Sepsis, Burn Injury, Pancreatic Stone Protein
- Medical subject headings
- Sepsis, Burns, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSP MonitoringDevice
PSP measurements will be obtained:
- Within 24 hours of Burn ICU admission (baseline)
- Week days during the ICU stay up to 45 days
- If a patient in the unblinded arm is over 200 ng/mL for PSP OR their values have doubled once in the previous 3 days, one weekend test will be performed.
- If a patient in the blinded arm is actively undergoing sepsis management, one weekend test will be performed.
- Additionally at times of acute clinical deterioration or new concern for infection, at the discretion of the clinical team
| Study group | Role | What they receive |
|---|---|---|
| Control Arm: Blinded PSP Monitoring (Standard of Care) | Active comparator | Participants randomized to the control arm will have PSP levels measured according to the study schedule; however, PSP results will be blinded to the treating clinical team and will not be used to guide clinical decision-making. PSP values will be recorded in a secure research database accessible only to the study team. Clinical management, including decisions regarding antibiotics, cultures, and sepsis evaluation, will follow standard Burn practice based on clinical assessment and existing laboratory and physiologic data. Receives: Device: PSP Monitoring |
| Intervention Arm: Unblinded PSP-Guided Management | Active comparator | Participants randomized to the intervention arm will have PSP results made available to the treating clinical team in real time. Clinical management will be guided/augmented by the predefined PSP-based algorithm integrated with clinical judgment. Receives: Device: PSP Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from sepsis onset to initiation (order) of empiric antibiotics
Measured: From enrollment to end of ICU stay, or 45 inpatient days, whichever is sooner.
Secondary outcomes (11)
Incidence of confirmed sepsis
Measured: From enrollment to end of ICU stay, or 45 inpatient days, whichever is sooner.
Time from sepsis onset to discontinuation of vasopressors for ≥24 consecutive hours
Measured: From enrollment to end of ICU stay, or 45 inpatient days, whichever is sooner
Antibiotic exposure rate
Measured as antibiotic days of therapy per 100 ICU days and per 100 hospital days
Measured: From enrollment to end of ICU stay, or 45 inpatient days, whichever is sooner.
Antibiotic-free days through day 28
Measured: From enrollment to day 28 of ICU stay, or ICU discharge, whichever is sooner.
Average ICU length of stay
Measured: From admission/enrollment to ICU discharge, up to 18 months.
Rate of in-hospital mortality
Measured: From admission to hospital discharge or expiration, up to 18 months.
Frequency and timing of diagnostic evaluation for infection
Measured: From enrollment to end of ICU stay, or 45 inpatient days, whichever is sooner.
Rate of recurrent sepsis episodes during the index hospitalization
Sepsis episodes defined by Sepsis-3 Criteria
Measured: From enrollment to end of ICU stay, or 45 inpatient days, whichever is sooner.
Rate of acute kidney injury
Measured: From enrollment to end of ICU stay, or 45 inpatient days, whichever is sooner.
Frequency of C. difficile infections
Measured: From enrollment to end of ICU stay, or 45 inpatient days, whichever is sooner.
Frequency of algorithm overrides in the PSP-guided arm
Measured: From enrollment to end of ICU stay, or 45 inpatient days, whichever is sooner.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abionic SA
- Responsible party
- Sponsor
- Investigators
- Brian Schneider, MD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866521
- Sponsor's protocol ID
- IRB-FY2026-216
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be made publicly available because of participant privacy considerations and institutional policies regarding the sharing of clinical research data.
Publications
Tedesco DJ, Hutter MF, Khalaf F, Ricciuti Z, Jeschke MG. Sepsis in burn care: incidence and outcomes. Mil Med Res. 2025 Sep 1;12(1):55. doi: 10.1186/s40779-025-00643-x.
PubMed 40890875Rech MA, Mosier MJ, McConkey K, Zelisko S, Netzer G, Kovacs EJ, Afshar M. Outcomes in Burn-Injured Patients Who Develop Sepsis. J Burn Care Res. 2019 Apr 26;40(3):269-273. doi: 10.1093/jbcr/irz017.
PubMed 30805641Filippidis P, Hovius L, Tissot F, Orasch C, Fluckiger U, Siegemund M, Pagani JL, Eggimann P, Marchetti O, Lamoth F; Fungal Infection Network of Switzerland (FUNGINOS). Serial monitoring of pancreatic stone protein for the detection of sepsis in intensive care unit patients with complicated abdominal surgery: A prospective, longitudinal cohort study. J Crit Care. 2024 Aug;82:154772. doi: 10.1016/j.jcrc.2024.154772. Epub 2024 Mar 11.
PubMed 38471247de Hond TAP, Oosterheert JJ, van Hemert-Glaubitz SJM, Musson REA, Kaasjager KAH. Pancreatic Stone Protein as a Biomarker for Sepsis at the Emergency Department of a Large Tertiary Hospital. Pathogens. 2022 May 9;11(5):559. doi: 10.3390/pathogens11050559.
PubMed 35631080Klein HJ, Niggemann P, Buehler PK, Lehner F, Schweizer R, Rittirsch D, Fuchs N, Waldner M, Steiger P, Giovanoli P, Reding T, Graf R, Plock JA. Pancreatic Stone Protein Predicts Sepsis in Severely Burned Patients Irrespective of Trauma Severity: A Monocentric Observational Study. Ann Surg. 2021 Dec 1;274(6):e1179-e1186. doi: 10.1097/SLA.0000000000003784.
PubMed 31972652