Inflammation and the Host Response to Injury (Burns)

Completed

• Conditions: Trauma; Multiple Organ Failure; Burns

• Registration Number: NCT00257244
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The purpose of this study is to help improve our understanding of the biology involved in the body's response to serious trauma or burn injury. The host response to trauma and burns is a collection of physiological and pathophysiological processes that depend critically upon the regulation of the human innate immune system, with particular emphasis on the inflammatory component of that system. No single research center or small group of centers has the capacity to delineate the integrated response of this complex biological system, which involves multiple molecular and genetic interactions that vary in time. Our proposal promotes the identification of important dynamic relationships that regulate the integration of this complex biological system, with the expectation that this understanding will ultimately impact the diagnosis, prognosis, and treatment of the hospitalized, severely injured patient.

Detailed Description

This large-scale collaborative project provides the means to acquire the necessary new knowledge directly in humans. Knowledge will be acquired using diverse state-of-the-art genomic and proteomic technologies, a highly complex clinical, proteomic, and genomic database, as well as newly-developed, novel analytical tools to probe this complex dataset. Our analytical capabilities at the genomic and proteomic level are now rapidly evolving and our ability to link these genomic and proteomic data to pathways and functional modules will help us more closely link this cellular data to immunological processes and ultimately, to the phenotypic response (i.e., trajectory) in the injured host. As a result, potential interventions, whether through our Program or other funding mechanisms, can be more effectively designed.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-11-18
• Study First Submitted QC: 2005-11-18
• Study First Posted: 2005-11-22
• Primary Completion: 2013-09
• Study Completion: 2018-09
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• Burn patients of all ages with 20% or greater of total body surface area burns that require surgical treatment
• Burn patients admitted to the burn unit within 96 hours (4 days) of burn injury

All patients meeting these criteria are entered into the epidemiologic database and assessed for specific exclusion criteria to establish whether serial blood draws are warranted.

Exclusion Criteria

• Injury caused by chemical agent
• Deep injury caused by conduction of electrical current or charge
• Decision not to treat due to severity of injury
• Anoxic brain injury that is not expected to result in complete recovery
• Associated multiple injuries exclusive of burns (ISS >=25)
• Pre-morbid condition: Severe congestive heart failure (measured ejection fraction <20%)
• Pre-morbid condition: Malignancy currently under treatment
• Pre-morbid condition: Medical condition requiring systemic glucocorticoid treatment
• Pre-morbid condition: current systemic immunosuppression for organ transplant or chronic inflammatory condition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to death	Within two years of burn injury
Change in gene expression after burn injury	Up to two years after burn injury
Number and type of complications	Up to two years after burn injury

Trial Locations

Locations (4)

Harborview Medical Center at University of Washington; 🇺🇸 Seattle, Washington, United States

Loyola University Medical Center at Loyola in Chicago; 🇺🇸 Maywood, Illinois, United States

Southwestern Medical Center at University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States

University of Texas at Galveston-Shriners Burn Hospital- Galveston; 🇺🇸 Galveston, Texas, United States