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

This study is currently recruiting participants.
Verified August 2012 by University Hospital, Grenoble
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
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
Stress, Psychological
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 17, 2014