NCT02457663

Identification and Validation of Biomarkers for Infections in Burns

Identification and Validation of Established and Novel Biomarkers for Infections in Burns

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 19 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In this prospective, multi-center study, 200 patients from four participating Texas burn hospitals will be enrolled from admission to discharge. The clinical research study team will collect approximately 11 serum samples and clinical data related to sepsis and infection predictors from severely burned adult patients, ages 18-80 years old. All serum samples from participating sites will be shipped to the lead site, University of Texas Medical Branch. The University of Texas Medical Branch will then validate previously identified biomarkers while simultaneously identifying novel biomarkers through discovery proteomics.

Detailed description

The burn literature is replete with suggested biomarkers of infections for identifying sepsis or other infections in burn patients, however, these reports are largely untested. In order for incorporation of infection biomarker assessment to become the standard of care, validation of these markers in a multi-center prospective study is necessary. As the majority of these biomarkers have been chosen because of success in other patient populations, or ease of measurement, it is possible that the best biomarkers of infection have not yet been discovered in this patient population. Prospective identification and validation of novel biomarkers may also improve early identification of infections in burn patients. Early treatment of infections and sepsis directly correlated with improved survival and reduced costs of care. In this prospective, multi-center study, 200 patients from four participating Texas burn hospitals will be enrolled from admission to discharge. The clinical research study team will collect approximately 11 serum samples and clinical data related to sepsis and infection predictors from severely burned adult patients, ages 18-80 years old. All serum samples from participating sites will be shipped to the lead site, University of Texas Medical Branch. The University of Texas Medical Branch will then validate previously identified biomarkers while simultaneously identifying novel biomarkers through discovery proteomics.

Conditions

• Burns Involving 20% or More of Body Surface

Interventions

Type	Name	Description
PROCEDURE	Blood Draw	Blood is to be collected at admission, prior to the 1st operating procedure, once daily for the following 7 consecutive days, at day 15, and at discharge (11 blood draws total). Blood will be taken from IV catheter or routine venipuncture if the catheter is not in place. The blood draw will occur prior to the induction of anesthesia or operating surgical procedure.

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-10-01
• Completion: 2019-07-11
• First posted: 2015-05-29
• Last updated: 2019-09-24

Locations

3 sites across 1 country: United States