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

NCT ID: NCT00791310

Last Updated: 2010-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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Severe Sepsis

Keywords

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Medical ICU Severe sepsis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TEP

Performance of of TEP coupled to scanner X

Group Type EXPERIMENTAL

Flucis

Intervention Type DRUG

FDG injected i.v

Interventions

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Flucis

FDG injected i.v

Intervention Type DRUG

Other Intervention Names

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FDG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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CHU Nancy

Principal Investigators

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sebastien Gibot, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU NANCY

Locations

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CHU; Central Hospital

Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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sebastien GIBOT, MD, PhD

Role: CONTACT

Phone: +33 3 83 85 29 70

Email: [email protected]

Facility Contacts

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sebastien md gibot, PhD

Role: primary

Other Identifiers

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2008-A00780-55

Identifier Type: -

Identifier Source: secondary_id

V1 01/03/2008

Identifier Type: -

Identifier Source: org_study_id