Bio-clinical Evolutive Dynamic in Patients Suffering From Communitary Septic Shock (Biosepsis)

NCT ID: NCT01668329

Last Updated: 2015-01-19

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

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-10-31

Brief Summary

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Septic shock is a frequent pathology responsible for over 30000 deaths/year in France. Its outcome has not been improved despite the knowledge on inflammatory processes; a reason for these lack of results may lay on the lack of data on the precise dynamics of inflammatory and anti-inflammatory cascades and their consequences. We intend to achieve accurate monitoring of the inflammatory process on a small group of non-immunocompromised patients. Our goal is to obtain quality data, repeated over time, by limiting the technical variability.

Detailed Description

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The aim is to obtain precise data on the dynamics of cytokines, oxydative stress and hormonal response on immunocompetent adults during septic shock.

Conditions

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Immunocompetent Patient on Septic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient over 18 years admitted in ICU.
* Clinical evidence of infection, suspected or proved, during the 48hrs following the hospital entry.
* Systemic inflammatory response syndrome.
* Shock defined as arterial hypotension (\<90mmHg)not responding to adequated filling.

Exclusion Criteria

* Minors
* Patient under guardianship or trusteeship
* Pregnant or lactating women
* Not affiliated to the social security
* Deprived of liberty by court decision
* Patients hospitalised without their approval
* Shock related to another cause than infection
* Long term corticothérapy
* On-going chemiothérapy, AIDS
* Bedridden patient
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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AdministrateurDRC

Pr JF TIMSIT

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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TIMSIT Jean FRANCOIS, PU/PH

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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University Hospital Grenoble

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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2009-A00822-55

Identifier Type: -

Identifier Source: org_study_id

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