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

January 16, 2015 updated by: AdministrateurDRC, University Hospital, Grenoble
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • University Hospital Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All immunocompetent patients hospitalised in intensive care from the beginning of the septic shock state.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evolutive profile of the inflammatory response during septic shock
Time Frame: Hospitalisation in ICU
Hospitalisation in ICU

Secondary Outcome Measures

Outcome Measure
Time Frame
Research for early prognosis factors
Time Frame: Hospitalisation in ICU
Hospitalisation in ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: TIMSIT Jean FRANCOIS, PU/PH, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

July 8, 2010

First Submitted That Met QC Criteria

August 14, 2012

First Posted (Estimate)

August 20, 2012

Study Record Updates

Last Update Posted (Estimate)

January 19, 2015

Last Update Submitted That Met QC Criteria

January 16, 2015

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-A00822-55

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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