An interventional study of PSP Monitoring in Sepsis, Burn and Inflammation, sponsored by Texas Tech University Health Sciences Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Texas Tech University Health Sciences Center · Not applicable, Interventional, and Screening
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:
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:
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 120 is above the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Texas Tech University Health Sciences Center is the lead sponsor of 98 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: PSP Monitoring
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.
Device: PSP Monitoring
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
Time from sepsis onset to initiation (order) of empiric antibiotics
Time frame: From enrollment to end of ICU stay, or 45 inpatient days, whichever is sooner.
Incidence of confirmed sepsis
Time frame: 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
Time frame: 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
Time frame: From enrollment to end of ICU stay, or 45 inpatient days, whichever is sooner.
Antibiotic-free days through day 28
Time frame: From enrollment to day 28 of ICU stay, or ICU discharge, whichever is sooner.
Average ICU length of stay
Time frame: From admission/enrollment to ICU discharge, up to 18 months.
Rate of in-hospital mortality
Time frame: From admission to hospital discharge or expiration, up to 18 months.
Frequency and timing of diagnostic evaluation for infection
Time frame: 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
Time frame: From enrollment to end of ICU stay, or 45 inpatient days, whichever is sooner.
Rate of acute kidney injury
Time frame: From enrollment to end of ICU stay, or 45 inpatient days, whichever is sooner.
Frequency of C. difficile infections
Time frame: From enrollment to end of ICU stay, or 45 inpatient days, whichever is sooner.
Frequency of algorithm overrides in the PSP-guided arm
Time frame: From enrollment to end of ICU stay, or 45 inpatient days, whichever is sooner.
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Texas Tech University Health Sciences Center