Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
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.
The main judgement criteria will be the percentage of the MtOe exams proved to be useful for diagnosis and/or associated with therapeutic modifications.
This pilot study will make it possible to evaluate the interest of the early realization of a TEP/scanner X examination among severe sepsis patients of unknown origin.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TEP Performance of of TEP coupled to scanner X |
Drug: Flucis
FDG injected i.v
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications. [28 days]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
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Age over 80
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Immunocompromised status
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Surgical intervention within the previous month
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Hemodynamic instability (defined by the use of more than 0.5µg/kg/min vasopressors)
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Severe hypoxia (defined by a PaO2/FiO2 ratio lower than 150)
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Pregnancy
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Patient already included in another protocol
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Anaphylaxis to Flucis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU; Central Hospital | Nancy | France | 54000 |
Sponsors and Collaborators
- Central Hospital, Nancy, France
Investigators
- Principal Investigator: sebastien Gibot, MD, PhD, CHU Nancy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- V1 01/03/2008
- 2008-A00780-55