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OpenTrials
Completed

NCT Number: NCT00257244

Inflammation and the Host Response to Injury (Burns)

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time to death

    Time frame: Within two years of burn injury

  2. Change in gene expression after burn injury

    Time frame: Up to two years after burn injury

  3. Number and type of complications

    Time frame: Up to two years after burn injury

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Inflammation and the Host Response to Injury

Important dates

Study start
2004
Primary completion
2013
Study completion
2018
First posted
Nov 22, 2005
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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