Inflammation and the Host Response to Injury (Burns)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Ronald G Tompkins, National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00257244
First received: November 18, 2005
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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
Trauma
Burns
Multiple Organ Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammation and the Host Response to Injury

Resource links provided by NLM:


Further study details as provided by National Institute of General Medical Sciences (NIGMS):

Primary Outcome Measures:
  • Time to death [ Time Frame: Within two years of burn injury ] [ Designated as safety issue: No ]
  • Change in gene expression after burn injury [ Time Frame: Up to two years after burn injury ] [ Designated as safety issue: No ]
  • Number and type of complications [ Time Frame: Up to two years after burn injury ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma, blood leukocyte nucleic acids (RNA), solid tissue nucleic acids (only RNA, no DNA)


Estimated Enrollment: 280
Study Start Date: April 2004
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Acute hospitalized burn patients

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257244

Locations
United States, Illinois
Loyola University Medical Center at Loyola in Chicago
Maywood, Illinois, United States, 60153
United States, Texas
Southwestern Medical Center at University of Texas Southwestern
Dallas, Texas, United States, 75390
University of Texas at Galveston-Shriners Burn Hospital- Galveston
Galveston, Texas, United States, 77550
United States, Washington
Harborview Medical Center at University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Investigators
Principal Investigator: Ronald G. Tompkins, MD, ScD Massachusetts General Hospital
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Ronald G Tompkins, Chief, Burns Service, National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier: NCT00257244     History of Changes
Other Study ID Numbers: 2 U54 GM062119_burn, 2 U54 GM062119
Study First Received: November 18, 2005
Last Updated: June 5, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by National Institute of General Medical Sciences (NIGMS):
Immunity, innate
Inflammation
Genomics
Proteomics

Additional relevant MeSH terms:
Burns
Inflammation
Multiple Organ Failure
Wounds and Injuries
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on August 27, 2014