Biomarkers in Necrotizing Soft Tissue Infections - Effects of Hyperbaric Oxygen Treatment on the Immune Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- IL-6 as a marker of treatment effects after HBOT
研究概览
简要总结
The purpose of this study is to investigate the effects of hyperic oxygen treatment on the immune response in patients with necrotizing soft tissue infections
详细描述
Necrotizing soft tissue infections (NSTI) is a complex, multi-factorial disease and the bacteria show a diverse microbial etiology. The exentisive inflammatory response caused by these bacteria is thought to be a main course of death. In Denmark, most NSTI patients are treated with hyperic oxygen therapy (HBOT). However, the effects of HBOT have never been investigated in NSTI patients.
Location: Copenhagen University Hospital, Rigshospitalet, Denmark.
Design: Observational cohort study.
Cohort: NSTI patients in Denmark treated with HBOT.
Biomarkers: Cytokines, acute-phase proteins, vasoactive biomarkers and other inflammatory biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
IL-6 as a marker of treatment effects after HBOT
时间窗: Change from baseline in IL-6 concentration after first HBOT administered during the first 24 hours of admission
次要结局
- SOFA score assessment(During the first 7 days of ICU admission)
- Inflammatory biomarkers as indicators of treatment effects after HBOT(The first 5 days of admission)
- Mortality(30, 90, 180 days)
- APACHE II assessment(During the first 7 days of ICU admission)
- Microbial etiology results from blood and tissue samples(During the first 7 days of ICU admission)
- SAPS II assessment(During the first 24 hours of ICU admission)
- LRINEC score assessment(During the first 7 days of ICU admission)
- Number of debridements(During the first 7 days of ICU admission)
- Vasoactive biomarkers as indicators of treatment effects after HBOT(The first 5 days of admission)
- Multiple organ failure assessed by the MODS score(During the first 7 days of ICU admission)
- Amputation rate(During the first 7 days of ICU admission)
- Anaya score assessment(During the first 7 days of ICU admission)
研究者
Ole Hyldegaard
MD, PhD, DMSci
Rigshospitalet, Denmark