Inflammatory Response in Polytraumatized Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Inflammatory pattern of complement activation, biomarkers and complement-regulating proteins (CRegs)on leukocytes
研究概览
简要总结
The purpose of this study is to determine the inflammatory response after multiple trauma in humans.
详细描述
Polytraumatized patients are via a systemic inflammatory response syndrome at high risk for an uneventful outcome in the posttraumatic phase. One of the main functions of the inflammatory response is the recognition and elimination of damaged tissues and microorganisms. In polytraumatized patients, a huge amount of damaged cells occurs which has to be eliminated by programmed cell death (apoptosis)without damaging surrounding tissues. It remains unclear whether, when and how an interplay of complement system, NF-kB, danger and pattern recognition receptors, apoptosis, mesenchymal stem cells and their regulation may be beneficial and harmful. Differing activation of the complement system, pro-inflammatory biomarkers and predisposing polymorphisms of response and receptor genes are expected to lead to varying outcome. Therefore, this prospective observational study will enroll n=60 polytraumatized patients with an ISS>18 to monitor longitudinally their inflammatory response after trauma and to find out whether there is a discriminating pattern of the cross talk between complement system, biomarkers and apoptosis in patients with beneficial or harmful outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •multiple trauma injury, injury severity score (ISS) > 18 with
- •isolated fractures of the extremities
- •fractures of the extremities combined with blunt/penetrating visceral trauma
- •fractures of the extremities combined with blunt/penetrating thoracic trauma
- •isolated head injury with morphological changes in CCT
- •combination of points 1 - 4
排除标准
- •life expectancy < 24 hours
- •participation in other trials
- •ISS < 18
- •cardiopulmonary reanimation on the accident scene or dying immediately after hospital admission
- •age < 18 years
- •known or suspected pregnancy
- •patients with ray-treatment or chemotherapy within the last three months
结局指标
主要结局
Inflammatory pattern of complement activation, biomarkers and complement-regulating proteins (CRegs)on leukocytes
时间窗: 0, 1, 4, 12, 24, 48, 96, 120 und 240 h after trauma
次要结局
- inflammatory biomarkers, cell surface markers, apoptosis, functional polymorphisms, mesenchymal stem cells, severity of injury (ISS), infections, SIRS, sepsis, shock, organ dysfunctions, severity of disease, ICU length of stay, wound healing, mortality(0, 1, 4, 12, 24, 48, 96, 120 und 240 h after trauma for biochemical and immunological parameters; ISS on admission; scores on a daily basis; ICU and hospital death on discharge)
研究者
Manfred Weiss
Professor, MD, MBA
University of Ulm
