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
Information provided by (Responsible Party):
AdministrateurDRC, University Hospital, Grenoble
First received: July 8, 2010
Last updated: August 14, 2012
Last verified: August 2012
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.
Immunocompetent Patient on Septic Shock
||Observational Model: Cohort
Time Perspective: Prospective
||Bio-clinical Evolutive Dynamic in Patients Suffering From Communitary Septic Shock (Biosepsis)
Primary Outcome Measures:
- Evolutive profile of the inflammatory response during septic shock [ Time Frame: Hospitalisation in ICU ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Secondary Outcome Measures:
- Research for early prognosis factors [ Time Frame: Hospitalisation in ICU ] [ Designated as safety issue: No ]
hormons, inflammatory markers, vitamines recovered from the patients serum.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2013 (Final data collection date for primary outcome measure)
The aim is to obtain precise data on the dynamics of cytokines, oxydative stress and hormonal response on immunocompetent adults during septic shock.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
All immunocompetent patients hospitalised in intensive care from the beginning of the septic shock state.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668329
University Hospital, Grenoble
||TIMSIT Jean FRANCOIS, PU/PH
||University Hospital, Grenoble
No publications provided
||AdministrateurDRC, Pr JF TIMSIT, University Hospital, Grenoble
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 8, 2010
||August 14, 2012
||France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Keywords provided by University Hospital, Grenoble:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2013
Systemic Inflammatory Response Syndrome