Clinical trial NCT00791310: Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology
Official title: Phase 3b,Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Severe Sepsis
Keywords: Medical ICU
Severe sepsis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2008-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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:

* 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

Primary outcomes:
measure: Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications.
timeFrame: 28 days
Secondary outcomes:
measure: 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
timeFrame: 28 days
measure: Reproducibility of the interpretations carried out under the conditions of protocol
timeFrame: 28 days
measure: Frequency of the medical and technical complications associated with the procedure
timeFrame: 28 days
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHU; Central Hospital
Study officials:
affiliation: CHU NANCY
name: sebastien Gibot, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: