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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01668329
First Posted: August 20, 2012
Last Update Posted: January 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AdministrateurDRC, University Hospital, Grenoble
  Purpose
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.

Condition
Immunocompetent Patient on Septic Shock

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bio-clinical Evolutive Dynamic in Patients Suffering From Communitary Septic Shock (Biosepsis)

Resource links provided by NLM:


Further study details as provided by AdministrateurDRC, University Hospital, Grenoble:

Primary Outcome Measures:
  • Evolutive profile of the inflammatory response during septic shock [ Time Frame: Hospitalisation in ICU ]

Secondary Outcome Measures:
  • Research for early prognosis factors [ Time Frame: Hospitalisation in ICU ]

Biospecimen Retention:   Samples Without DNA
hormons, inflammatory markers, vitamines recovered from the patients serum.

Enrollment: 64
Study Start Date: September 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Detailed Description:
The aim is to obtain precise data on the dynamics of cytokines, oxydative stress and hormonal response on immunocompetent adults during septic shock.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All immunocompetent patients hospitalised in intensive care from the beginning of the septic shock state.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668329


Locations
France
University Hospital Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: TIMSIT Jean FRANCOIS, PU/PH University Hospital, Grenoble
  More Information

Responsible Party: AdministrateurDRC, Pr JF TIMSIT, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01668329     History of Changes
Other Study ID Numbers: 2009-A00822-55
First Submitted: July 8, 2010
First Posted: August 20, 2012
Last Update Posted: January 19, 2015
Last Verified: August 2012

Keywords provided by AdministrateurDRC, University Hospital, Grenoble:
Septic shock
Inflammatory process
Cytokines
Hormonal response
Oxydative stress

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation