Identification and Validation of Biomarkers for Infections in Burns
Identification and Validation of Established and Novel Biomarkers for Infections in Burns
研究概览
详细说明
The burn literature is replete with suggested biomarkers of infections for identifying sepsis or other infections in burn patients, however, these reports are largely untested. In order for incorporation of infection biomarker assessment to become the standard of care, validation of these markers in a multi-center prospective study is necessary. As the majority of these biomarkers have been chosen because of success in other patient populations, or ease of measurement, it is possible that the best biomarkers of infection have not yet been discovered in this patient population. Prospective identification and validation of novel biomarkers may also improve early identification of infections in burn patients. Early treatment of infections and sepsis directly correlated with improved survival and reduced costs of care.
In this prospective, multi-center study, 200 patients from four participating Texas burn hospitals will be enrolled from admission to discharge. The clinical research study team will collect approximately 11 serum samples and clinical data related to sepsis and infection predictors from severely burned adult patients, ages 18-80 years old. All serum samples from participating sites will be shipped to the lead site, University of Texas Medical Branch. The University of Texas Medical Branch will then validate previously identified biomarkers while simultaneously identifying novel biomarkers through discovery proteomics.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Texas
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Dallas、Texas、美国、75390
- University of Texas Southwestern Medical Center
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Fort Sam Houston、Texas、美国、78234
- U.S. Army Institute of Surgical Research
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Houston、Texas、美国、77030
- University of Texas Health Science Center at Houston
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Ages 18-80 years old
- Greater than 20% Total Body Surface Area burn
- Patient arrival to the burn center within 7 days of burn injury
Exclusion Criteria:
- Known history of acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC), human immunodeficiency virus (HIV)
- History of cancer within 5 years
- Pregnancy
- Burn injury due to chemical burns or deep electrical injury
- Inability to obtain informed consent
- Decision not to treat due to burn injury severity or futility as deemed by the clinical team at the time of admission (Note: This is a clinical determination of futility beyond which survival is rare. These are typically patients whose sum of Total Body Surface Area % burn and age (Baux score) exceeds 140 or 120 with severe inhalation injury.)
- Presence of anoxic brain injury that is not expected to result in complete recovery
学习计划
研究是如何设计的?
设计细节
- 观测模型:生态或社区
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Incidence of infectious and septic episodes
大体时间:1.5 years
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1.5 years
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合作者和调查者
调查人员
- 首席研究员:Celeste C Finnerty, Ph.D.、University of Texas
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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