Phase 3b,Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications.
研究概览
简要总结
The objective of this pilot study is to estimate a procedure where the biological samples routinely obtained at the site of suspected infection could be guided by the early realization of a TEP with FDG coupled to scanner X, in patients hospitalized in ICU for severe sepsis of unspecified etiology.
详细描述
Severe sepsis constitutes the leading cause of mortality in ICU, in particular because a microbial documentation is lacking in about half of the cases.
Tomography by emission of positons, which uses the property of activated macrophages and leucocytes to collect 18F-fluorodeoxyglucose may prove useful to identify the site(s) of infection and then guide sampling.
Thirty patients will be included over 12 months.
Within 24 hours after admission, patients presented with a severe sepsis of still unknown etiology will benefit from the realization of a morphoTEP, including an examination MtOe with the FDG, associated with a conventional scanner X.
Suspected infected sites will then be the subject of sampling when possible. These samples will be send for microbial culture, histology and TREM-1 expression (membrane-bound and soluble form) when appropriate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Patient hospitalized with severe sepsis
- •Absence of infected site clearly identified after 48 hours of a conventional diagnosis assessment or suspicion of one or more additional sites
- •Indication of scanner X with injection
- •Informed consent obtained
排除标准
- •Age over 80
- •Immunocompromised status
- •Surgical intervention within the previous month
- •Hemodynamic instability (defined by the use of more than 0.5µg/kg/min vasopressors)
- •Severe hypoxia (defined by a PaO2/FiO2 ratio lower than 150)
- •Pregnancy
- •Patient already included in another protocol
- •Anaphylaxis to Flucis
研究组 & 干预措施
TEP
Performance of of TEP coupled to scanner X
干预措施: Flucis (Drug)
结局指标
主要结局
Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications.
时间窗: 28 days
次要结局
- Percentage of patients for whom local determinations of TREM and sTREM will have made it possible to identify a strong probability of infection of one or more suspected site(28 days)
- Reproducibility of the interpretations carried out under the conditions of protocol(28 days)
- Frequency of the medical and technical complications associated with the procedure(28 days)