PSP Monitoring for Sepsis in Burns
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Brian Schneider, MD
Principal Investigator
Texas Tech University Health Sciences Center
Are You a Good Fit for This Trial?
This trial is for adults with serious burn injuries who are admitted to the intensive care unit. Participants must be able to have blood samples taken and receive standard treatment for burns and possible sepsis.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- PSP Monitoring
Trial Overview
The study tests if using a blood test called PSP helps doctors detect and treat sepsis earlier in burn patients. Patients are randomly assigned to either have their PSP results used by doctors or not, while all get usual ICU care.
How Is the Trial Designed?
2
Treatment groups
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Texas Tech University Health Sciences Center
Lead Sponsor
Abionic SA
Industry Sponsor
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