Sepsis Biomarker Monitoring in Burn Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorTexas Tech University Health Sciences Center
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 - 89 years
Diagnosed with Burn injury of any mechanism
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.
Expected ICU stay > 48 hours
Disqualifiers
Inability to approach/consent within 24 hours after the time of injury
Existing sepsis requiring antibiotics within 24 hours of admission
Prisoners
Incomplete chart data
Trial design
Design model
Parallel
Treatments tested in this trial
PSP Monitoring
DevicePSP 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
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Control Arm: Blinded PSP Monitoring (Standard of Care)Active comparator 1 intervention
Group B: Intervention Arm: Unblinded PSP-Guided ManagementActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
Incidence of confirmed sepsis
Time frame
From enrollment to end of ICU stay, or 45 inpatient days, whichever is sooner.2
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 sooner3
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.4
Antibiotic-free days through day 28
Time frame
From enrollment to day 28 of ICU stay, or ICU discharge, whichever is sooner.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Texas Tech University Health Sciences Center
Lead sponsor
Abionic SA
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: