Inflammation and the Host Response to Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 4
- 主要终点
- Time to death
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Time to death
时间窗: Within two years of burn injury
Change in gene expression after burn injury
时间窗: Up to two years after burn injury
Number and type of complications
时间窗: Up to two years after burn injury
次要结局
未报告次要终点
研究者
Ronald G. Tompkins
Chief, Burns Service
Massachusetts General Hospital