ProTreat - Prognosis and Treatment of Necrotizing Soft Tissue Infections: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- suPAR as a biomarker of disease severity and prognosis in NSTI patients with and without septic shock
研究概览
简要总结
The investigators will analyze biomarkers related to the prognosis and treatment of necrotizing soft tissue infections (NSTI). The focus will be on whether certain endothelial and immune system biomarkers can function as markers of disease severity, mortality as well as the effects of hyperbaric oxygen therapy (HBOT). Biomarkers will be measured upon admission to an intensive care unit at Copenhagen University Hospital and during the following 3 days.
详细描述
Introduction:
Necrotizing soft-tissue infections (NSTI) are among the most serious and deadly infections known. They are characterized by rapidly progressing soft-tissue inflammation with necrosis and can quickly cause multiple organ failure and death. Mortality has been shown to be 25-35 %, with survivors coping with amputations and prolonged rehabilitation.
Currently, there is a lack of proper tools to evaluate the severity and prognosis of NSTI in individual patients. This results in necessary, yet sometimes overzealous surgical debridement, culminating in prolonged patient rehabilitation and invalidity. Hyperbaric oxygen therapy (HBOT) may be added as adjunctive therapy of NSTI. However, there is no clear understanding of the effectiveness of HBOT on NSTI. The investigators seek to remedy these two issues by examining multiple biomarkers over the course of several studies.
Methodology:
Location: Copenhagen University Hospital, Rigshospitalet, Denmark.
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
suPAR as a biomarker of disease severity and prognosis in NSTI patients with and without septic shock
时间窗: At admission
Association between plasma suPAR levels and NSTI mortality, and SAPS II and SOFA scores
sTM and sE-selectin as biomarkers of HBOT effect in NSTI patients
时间窗: At admission, and during the next 3 days in the ICU
Changes in plasma sTM and sE-selectin concentrations in NSTI patients, compared with the control group
次要结局
- Mortality(While in the ICU, and at 28, 90, 180 days)
- Vasopressor treatment(During ICU admission (expected average of 8 days))
- Biomarkers and disease severity(At admission, and the next 3 days in the ICU)
- Microbial etiology(During ICU admission (expected average of 8 days))
- Renal replacement therapy(During ICU admission (expected average of 8 days))
- HBOT and endothelial biomarkers(At admission, and the next 3 days in the ICU)
- Amputation rate(During ICU admission (expected average of 8 days))
- ICU scoring systems(During ICU admission (expected average of 8 days))
- Multiple organ failure(During ICU admission (expected average of 8 days))
- Debridements(During ICU admission (expected average of 8 days))
- Time from admission to primary hospital until first surgery/debridement(2 days)
- Ventilator treatment(During ICU admission (expected average of 8 days))
- Steroid treatment(Up to 7 days before surgical diagnose at primary hospital)
研究者
Ole Hyldegaard
Clinical Professor
Rigshospitalet, Denmark