Identification and Validation of Biomarkers for Infections in Burns

NCT02457663 | Terminated

• 1 other identifier: 14-0525
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Burns Involving 20% or More of Body Surface

Keywords

Burns

Outcome Measures

Primary Outcomes (1)

• Incidence of infectious and septic episodes

  1.5 years

Interventions

Blood Draw PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to participating burn centers who meet inclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (3)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

U.S. Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Burns

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Celeste C Finnerty, Ph.D.

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: May 29, 2015
• Study Start: April 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: July 11, 2019
• Last Updated: September 24, 2019

Record last verified: 2019-02

Locations

US (3)