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NOT YET RECRUITING
NCT07866521
NA

Sepsis Biomarker Monitoring in Burn Patients

Sponsor: Texas Tech University Health Sciences Center

View on ClinicalTrials.gov

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.

Official title: A Randomized Trial of Blinded vs Unblinded Sepsis Biomarker Monitoring in Burn Patients

Key Details

Gender

All

Age Range

18 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-11-01

Completion Date

2028-08-31

Last Updated

2026-10-08

Healthy Volunteers

No

Interventions

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

Locations (1)

Texas Tech University Health Sciences Center/ University Medical Center Lubbock

Lubbock, Texas, United States