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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University Hospital, Grenoble.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
AdministrateurDRC, University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01668329
First received: July 8, 2010
Last updated: August 14, 2012
Last verified: August 2012
  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 University Hospital, Grenoble:

Primary Outcome Measures:
  • Evolutive profile of the inflammatory response during septic shock [ Time Frame: Hospitalisation in ICU ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Research for early prognosis factors [ Time Frame: Hospitalisation in ICU ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

hormons, inflammatory markers, vitamines recovered from the patients serum.


Estimated Enrollment: 60
Study Start Date: September 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668329

Contacts
Contact: TIMSIT Jean François, PU/PH 0476768779 JFTimsit@chu-grenoble.fr

Locations
France
University Hospital Grenoble Recruiting
Grenoble, France, 38043
Contact: TIMSIT Jean Francois, PU/PH    0476768779    JFTimsit@chu-grenoble.fr   
Contact: TOURNEGROS Caroline, ARC    0476767109    CTournegros@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: TIMSIT Jean FRANCOIS, PU/PH University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: AdministrateurDRC, Pr JF TIMSIT, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01668329     History of Changes
Other Study ID Numbers: 2009-A00822-55
Study First Received: July 8, 2010
Last Updated: August 14, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by 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

ClinicalTrials.gov processed this record on October 19, 2014