Biomarkers in Necrotizing Soft Tissue Infections - Aspects of the Innate Immune Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- PTX3, NOx and IL-6 as early markers of disease severity in NSTI patients with and without septic shock
研究概览
简要总结
The purpose of this study is to investigate the immune response in patients with necrotizing soft tissue infections (NSTI). The investigation will focus on inflammatory and vasoactive biomarkers as prognostic markers of severity and mortality at admission to Rigshospitalet and the following 3 days
详细描述
Necrotizing soft tissue infection (NSTI) is a complex, multi-factorial disease with diverse microbiological etiology and varying co-morbidities. The rapidly spreading infection may cause extensive soft tissue damage, limb loss, and multiple organ failure. The incidence of NSTIs has increased over the past years and the fatality rates are still high despite increased focus on these patients (20-30%). The extensive inflammatory response is thought to be a main course of death. However, it is unknown which biomarkers that are responsible for the deleterious effects and how these molecular mediators are modulated during the infection and treatment regimes. Thus, there is a need for novel insight into the immune system disturbances in order to improve outcome of NSTIs.
Location: Copenhagen University Hospital, Rigshospitalet, Denmark.
Design: Observational cohort study.
Cohort: NSTI patients in Denmark.
Controls: 50-100 Patients undergoing elective, orthopedic surgery at Rigshospitalet.
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
PTX3, NOx and IL-6 as early markers of disease severity in NSTI patients with and without septic shock
时间窗: Admission, first 24 hours
Primary analysis: Association between PTX3-, NOx-, and IL6-concentration and septic shock (PTX3, NOx) or LRINEC ≥ 6 (IL-6) in NSTI patients at time of admission to Rigshospitalet
次要结局
- Multiple organ failure(During ICU admission (expected average of 8 days))
- Number of debridements(During ICU admission (expected average of 8 days))
- Time from admission to primary hospital until first surgery/debridement(2 days)
- Microbial etiology(During ICU admission (expected average of 8 days))
- Inflammatory biomarkers(Admission and the following 3 days)
- ICU-scoring systems(During ICU admission (expected average of 8 days))
- Vasoactive biomarkers(Admission and the following 3 days)
- Mortality(28, 90, 180 days)
- Amputation rate(During ICU admission (expected average of 8 days))
- Ventilator treatment, renal replacement therapy, vasopressor treatment during stay at ICU(During ICU admission (expected average of 8 days))
- Steroid treatment (injection/oral intake) up to development of NSTI(Up to 7 days before surgical diagnose at primary hospital)
- The effects of immunoglobulin on inflammatory biomarkers(Admission and the following 3 days)
- Biomarkers and Severity of disease(Admission and the following 3 days)
研究者
Ole Hyldegaard
Ole Hyldegaard
Rigshospitalet, Denmark