Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology
|ClinicalTrials.gov Identifier: NCT00791310|
Recruitment Status : Unknown
Verified December 2010 by Central Hospital, Nancy, France.
Recruitment status was: Recruiting
First Posted : November 14, 2008
Last Update Posted : December 31, 2010
|Condition or disease||Intervention/treatment||Phase|
|Severe Sepsis||Drug: Flucis||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3b,Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||October 2010|
|Estimated Study Completion Date :||October 2010|
Performance of of TEP coupled to scanner X
FDG injected i.v
Other Name: FDG
- Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications. [ Time Frame: 28 days ]
- 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 [ Time Frame: 28 days ]
- Reproducibility of the interpretations carried out under the conditions of protocol [ Time Frame: 28 days ]
- Frequency of the medical and technical complications associated with the procedure [ Time Frame: 28 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791310
|Contact: sebastien GIBOT, MD, PhD||+33 3 83 85 29 firstname.lastname@example.org|
|CHU; Central Hospital||Recruiting|
|Nancy, France, 54000|
|Contact: sebastien md gibot, PhD +33 3 83 85 29 70 email@example.com|
|Principal Investigator:||sebastien Gibot, MD, PhD||CHU Nancy|