Overview

This trial is active, not recruiting.

Condition burns involving 20% or more of body surface
Treatment blood draw
Sponsor The University of Texas Medical Branch, Galveston
Start date April 2015
End date January 2017
Trial size 200 participants
Trial identifier NCT02457663, 14-0525

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model ecologic or community
Time perspective prospective

Primary Outcomes

Measure
Incidence of infectious and septic episodes
time frame: 1.5 years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Ages 18-80 years old - Greater than 20% Total Body Surface Area burn - Patient arrival to the burn center within 7 days of burn injury Exclusion Criteria: - Known history of acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC), human immunodeficiency virus (HIV) - History of cancer within 5 years - Pregnancy - Burn injury due to chemical burns or deep electrical injury - Inability to obtain informed consent - Decision not to treat due to burn injury severity or futility as deemed by the clinical team at the time of admission (Note: This is a clinical determination of futility beyond which survival is rare. These are typically patients whose sum of Total Body Surface Area % burn and age (Baux score) exceeds 140 or 120 with severe inhalation injury.) - Presence of anoxic brain injury that is not expected to result in complete recovery

Additional Information

Official title Identification and Validation of Established and Novel Biomarkers for Infections in Burns
Principal investigator Celeste C Finnerty, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston.