Inflammation and the Host Response to Injury (Burns)

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00257244

Collaborator

(none)

280

Enrollment

Locations

173

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma Burns Multiple Organ Failure

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 Design

Study Type:

Observational

Anticipated Enrollment :

280 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Inflammation and the Host Response to Injury

Study Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2018

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loyola University Medical Center at Loyola in Chicago	Maywood	Illinois	United States	60153
2	Southwestern Medical Center at University of Texas Southwestern	Dallas	Texas	United States	75390
3	University of Texas at Galveston-Shriners Burn Hospital- Galveston	Galveston	Texas	United States	77550
4	Harborview Medical Center at University of Washington	Seattle	Washington	United States	98104