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Clinical Trials/NCT01668329
NCT01668329
Completed
Not Applicable

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

University Hospital, Grenoble1 site in 1 country64 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Immunocompetent Patient on Septic Shock
Sponsor
University Hospital, Grenoble
Enrollment
64
Locations
1
Primary Endpoint
Evolutive profile of the inflammatory response during septic shock
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
October 2012
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Principal Investigator
Principal Investigator

AdministrateurDRC

Pr JF TIMSIT

University Hospital, Grenoble

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Evolutive profile of the inflammatory response during septic shock

Time Frame: Hospitalisation in ICU

Secondary Outcomes

  • Research for early prognosis factors(Hospitalisation in ICU)

Study Sites (1)

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