Inflammation and the Host Response to Injury (Burns)

March 5, 2019 updated by: Ronald G. Tompkins, Massachusetts General Hospital

Inflammation and the Host Response to Injury

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center at Loyola in Chicago
    • Texas
      • Dallas, Texas, United States, 75390
        • Southwestern Medical Center at University of Texas Southwestern
      • Galveston, Texas, United States, 77550
        • University of Texas at Galveston-Shriners Burn Hospital- Galveston
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center at University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Acute hospitalized burn patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to death
Time Frame: Within two years of burn injury
Within two years of burn injury
Change in gene expression after burn injury
Time Frame: Up to two years after burn injury
Up to two years after burn injury
Number and type of complications
Time Frame: Up to two years after burn injury
Up to two years after burn injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Ronald G. Tompkins, MD, ScD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

November 18, 2005

First Submitted That Met QC Criteria

November 18, 2005

First Posted (Estimate)

November 22, 2005

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2 U54 GM062119_burn
  • U54GM062119 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Curated and validated data are available to Consortium Members

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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