[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659502":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":51,"studyPopulation":11,"armGroups":52,"interventions":63,"overallOfficials":69,"centralContacts":73,"locations":83,"responsibleParty":105,"collaborators":107,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":11,"eligibilityCriteria":117,"healthyVolunteers":113,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":11,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":133,"overallStatus":136,"whyStopped":11,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Texas Tech University Health Sciences Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Time from sepsis onset to initiation (order) of empiric antibiotics",null,"From enrollment to end of ICU stay, or 45 inpatient days, whichever is sooner.",[14,16,19,22,25,28,31,33,36,38,40],{"measure":15,"description":11,"timeFrame":12},"Incidence of confirmed sepsis",{"measure":17,"description":11,"timeFrame":18},"Time from sepsis onset to discontinuation of vasopressors for ≥24 consecutive hours","From enrollment to end of ICU stay, or 45 inpatient days, whichever is sooner",{"measure":20,"description":21,"timeFrame":12},"Antibiotic exposure rate","Measured as antibiotic days of therapy per 100 ICU days and per 100 hospital days",{"measure":23,"description":11,"timeFrame":24},"Antibiotic-free days through day 28","From enrollment to day 28 of ICU stay, or ICU discharge, whichever is sooner.",{"measure":26,"description":11,"timeFrame":27},"Average ICU length of stay","From admission\u002Fenrollment to ICU discharge, up to 18 months.",{"measure":29,"description":11,"timeFrame":30},"Rate of in-hospital mortality","From admission to hospital discharge or expiration, up to 18 months.",{"measure":32,"description":11,"timeFrame":12},"Frequency and timing of diagnostic evaluation for infection",{"measure":34,"description":35,"timeFrame":12},"Rate of recurrent sepsis episodes during the index hospitalization","Sepsis episodes defined by Sepsis-3 Criteria",{"measure":37,"description":11,"timeFrame":12},"Rate of acute kidney injury",{"measure":39,"description":11,"timeFrame":12},"Frequency of C. difficile infections",{"measure":41,"description":11,"timeFrame":12},"Frequency of algorithm overrides in the PSP-guided arm",{"allocation":43,"interventionModel":44,"interventionModelDescription":11,"primaryPurpose":45,"observationalModel":11,"timePerspective":11,"maskingInfo":46},"RANDOMIZED","PARALLEL","SCREENING",{"masking":47,"maskingDescription":48,"whoMasked":49},"SINGLE","To clarify, the treating clinical team is blinded to PSP results in the control arm.",[50],"CARE_PROVIDER","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.\n\nPancreatic 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.\n\nThis 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.\n\nThe 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.",[53,59],{"label":54,"type":55,"description":56,"interventionNames":57},"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.",[58],"Device: PSP Monitoring",{"label":60,"type":55,"description":61,"interventionNames":62},"Intervention Arm: Unblinded PSP-Guided Management","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\u002Faugmented by the predefined PSP-based algorithm integrated with clinical judgment.",[58],[64],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":11},"DEVICE","PSP Monitoring","PSP measurements will be obtained:\n\n* Within 24 hours of Burn ICU admission (baseline)\n* Week days during the ICU stay up to 45 days\n* If a patient in the unblinded arm is over 200 ng\u002FmL for PSP OR their values have doubled once in the previous 3 days, one weekend test will be performed.\n* If a patient in the blinded arm is actively undergoing sepsis management, one weekend test will be performed.\n* Additionally at times of acute clinical deterioration or new concern for infection, at the discretion of the clinical team",[54,60],[70],{"name":71,"affiliation":5,"role":72},"Brian Schneider, MD","PRINCIPAL_INVESTIGATOR",[74,79],{"name":75,"role":76,"phone":77,"phoneExt":11,"email":78},"Jennifer Kesey, PhD, APRN, FNP-BC, CNE","CONTACT","+1 806-743-4217","jennifer.kesey@ttuhsc.edu",{"name":80,"role":76,"phone":81,"phoneExt":11,"email":82},"Emily Vanderpool, PhD","+1 806-743-2370","emily.vanderpool@ttuhsc.edu",[84],{"facility":85,"status":11,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Texas Tech University Health Sciences Center\u002F University Medical Center Lubbock","Lubbock","Texas","79430","United States","US",{"type":92,"coordinates":93},"Point",[94,95],-101.85517,33.57786,{"lat":95,"lon":94},[98,101,104],{"name":99,"role":76,"phone":77,"phoneExt":11,"email":100},"Lane Young, BA, CCRC","lane.young@ttuhsc.edu",{"name":102,"role":76,"phone":77,"phoneExt":11,"email":103},"Chris Scott, MSN, RNC-P, CCRC, CA\u002FCP, SANE","chris.scott@ttuhsc.edu",{"name":71,"role":72,"phone":11,"phoneExt":11,"email":11},{"type":106,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[108],{"name":109,"class":110},"Abionic SA","INDUSTRY","100659502","sepsis-biomarker-monitoring-in-burn-patients-100659502",false,"NCT07866521","Sepsis Biomarker Monitoring in Burn Patients","A Randomized Trial of Blinded vs Unblinded Sepsis Biomarker Monitoring in Burn Patients","Inclusion Criteria:\n\n1. Adults aged 18 - 89 years\n2. Diagnosed with Burn injury of any mechanism\n3. Admitted to the Burn Surgical Team at UMC Hospital with a critical condition\u002FICU status. Critically ill burns overflowed to TSICU may still be enrolled.\n4. Expected ICU stay \\> 48 hours\n5. Subject will be approached during the first 24 hours after burn injury with an invitation to participate\n\nExclusion Criteria:\n\n1. Inability to approach\u002Fconsent within 24 hours after the time of injury\n2. Existing sepsis requiring antibiotics within 24 hours of admission\n3. Prisoners\n4. Incomplete chart data\n5. Acute or chronic pancreatitis\n6. Abdominal pathologies\n7. Advanced renal failure (acute or chronic)\n8. Pre-existing multiple organ failure\n9. Limited life span, expected death within 3 days of admission due to the severity of injury\n10. Lower acuity burns admitted to the burn stepdown.","ALL","18 Years","89 Years",{"count":122,"type":123},120,"ESTIMATED","INTERVENTIONAL",[126],"NA","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:\n\n* Does seeing PSP test results help doctors start the right antibiotics sooner?\n* Does using PSP reduce unnecessary antibiotic use?\n* Does using PSP improve recovery and other health outcomes?\n\nResearchers 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.\n\nParticipants will:\n\n* Be randomly assigned to one of the two study groups.\n* 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.\n* Receive the usual care for burn injuries and sepsis throughout the study.",[129,130,131,132],"Sepsis","Burn","Inflammation","Burn Infection",[129,134,135],"Burn Injury","Pancreatic Stone Protein","NOT_YET_RECRUITING","2026-10-05",{"date":139,"type":140},"2026-10-08","ACTUAL",{"date":142,"type":123},"2026-11-01",{"date":144,"type":123},"2028-08-31",{"name":5,"class":6},1]