Bio-clinical Evolutive Dynamic in Patients Suffering From Communitary Septic Shock (Biosepsis) (BIOSEPSIS)
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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) |
- Evolutive profile of the inflammatory response during septic shock [ Time Frame: Hospitalisation in ICU ] [ Designated as safety issue: No ]
- 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) |
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 |
All immunocompetent patients hospitalised in intensive care from the beginning of the septic shock state.
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| Contact: TIMSIT Jean François, PU/PH | 0476768779 | JFTimsit@chu-grenoble.fr |
| 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 | |
| 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 May 21, 2013