A Randomized Trial of Blinded vs Unblinded Sepsis Biomarker Monitoring in Burn Patients
Texas Tech University Health Sciences Center
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. 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? 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.
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 betw…
Eligibility
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults aged 18 - 89 years 2. Diagnosed with Burn injury of any mechanism 3. 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. 4. Expected ICU stay \> 48 hours 5. Subject will be approached during the first 24 hours after burn injury with an invitation to participate Exclusion Criteria: 1. Inability to approach/consent within 24 hours after the time of injury 2. Existing sepsis requiring antibiotics within 24 hours of admission 3. Prisoners 4. Incomplete chart data 5.…
Interventions
- DevicePSP 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
Location
- Texas Tech University Health Sciences Center/ University Medical Center LubbockLubbock, Texas