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Completed

NCT Number: NCT01668329

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

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.

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Key information

Conditions

Immunocompetent Patient on Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Grenoble

Grenoble, 38043, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evolutive profile of the inflammatory response during septic shock

    Time frame: Hospitalisation in ICU

Secondary outcomes

  1. Research for early prognosis factors

    Time frame: Hospitalisation in ICU

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: BIOSEPSIS

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 20, 2012
Registry last updated
Jan 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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