Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology

Central Hospital, Nancy, France

Status and phase

Unknown

Phase 3

Conditions

Severe Sepsis

Treatments

Drug: Flucis

Study type

Interventional

Funder types

Other

Identifiers

NCT00791310

V1 01/03/2008

2008-A00780-55

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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