Identification and Validation of Biomarkers for Infections in Burns

Burns Involving 20% or More of Body Surface Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02457663
• Other study ID #: 14-0525
• Status: Terminated
• Start date: April 2015
• Est. completion date: July 11, 2019

Study information

• Verified date: February 2019
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: July 11, 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Burns Involving 20% or More of Body Surface

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	U.S. Army Institute of Surgical Research	Fort Sam Houston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of infectious and septic episodes		1.5 years