French Registry Studying the Characteristics and Prognosis of Aortic and Large Arterial Vessel Infections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- one-year mortality
研究概览
简要总结
Aortic or large arterial vessel infections are rare but serious infections. Their management is based on French and American expert opinions. The quality of evidence supporting these guidelines is low because most publications on the subject correspond to case series and few interventional studies have been performed to validate their management. However, referral centres for vascular surgery are frequently solicited to give their opinion on patients suffering from mycotic aneurysms. In addition, the last few decades have seen the improvement of vascular surgery techniques allowing the management of more and more patients, often elderly and comorbid. There has therefore been an increase in the incidence of infectious complications associated with this care. It is therefore essential to participate in research on aortic and large arterial vessel infections. For this, a monocentric cohort study seems to be an essential first step to better understand the polymorphism and complexity of these patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Age ≥ 18 years
- •Aortic or large arterial vessel infection. The diagnosis is made on a number of criteria in favour of the diagnosis (at least 2 of the following 3 criteria):
- •Compatible clinical presentation: local or general inflammatory signs suggestive of a deep infection (fever, chills, scar discharge, fistula, febrile abdominal pain and low back pain, ...) or per-operative finding of an infection in contact with native or prosthetic vascular tissue
- •And/or biological (inflammatory syndrome) and/or imaging evidence (infectious sign on native, bioprosthetic or prosthetic vascular tissue on CT and/or PET scan) in favour of the diagnosis
- •And/or microbiological evidence (positive serologies, blood cultures or deep samples in favour of infection)
排除标准
- •Patient who objected to participation in this protocol and data collection
- •Pregnant woman, parturient or breastfeeding mother
- •Person deprived of liberty by a judicial or administrative decision,
- •Person subject to psychiatric care by virtue of articles L.3212-1 and L.3213-1 of the French public health code
- •Person subject to a legal protection measure
- •Person unable to give consent
结局指标
主要结局
one-year mortality
时间窗: one year after the diagnosis
Study of all-cause mortality in patients with aortic vascular infection and large arterial vessels during the first year of follow-up after diagnosis.
次要结局
- Identification of prognostic factors associated with arterial vascular infections(at the time of diagnosis and up to one year afterwards)
研究者
LEFEVRE Benjamin
Principal Investigator
Central Hospital, Nancy, France