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

Immunocompetent Patient on Septic Shock Clinical Trial

— BIOSEPSIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668329
• Other study ID #: 2009-A00822-55
• Status: Completed
• Phase: N/A
• First received: July 8, 2010
• Last updated: January 16, 2015
• Start date: September 2009
• Est. completion date: October 2012

Study information

• Verified date: August 2012
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Description:

The aim is to obtain precise data on the dynamics of cytokines, oxydative stress and hormonal response on immunocompetent adults during septic shock.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Immunocompetent Patient on Septic Shock
• Shock
• Shock, Septic

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolutive profile of the inflammatory response during septic shock		Hospitalisation in ICU	No
Secondary	Research for early prognosis factors		Hospitalisation in ICU	No