Immunocompetent Patient on Septic ShockBIOSEPSISNCT01668329
Bio-clinical Evolutive Dynamic in Patients Suffering From Communitary Septic Shock (Biosepsis)
An observational study of Immunocompetent Patient on Septic Shock, run by University Hospital, Grenoble at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunocompetent Patient on Septic Shock
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All immunocompetent patients hospitalised in intensive care from the beginning of the septic shock state.
Who may be able to join
- 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.
Who cannot join
- 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
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- Shock related to another cause than infection
- Long term corticothérapy
- On-going chemiothérapy, AIDS
- Bedridden patient
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Immunocompetent Patient on Septic Shock
- Keywords
- Septic shock, Inflammatory process, Cytokines, Hormonal response, Oxydative stress
- Medical subject headings
- Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolutive profile of the inflammatory response during septic shock
Measured: Hospitalisation in ICU
Secondary outcomes (1)
Research for early prognosis factors
Measured: Hospitalisation in ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startSep 2009
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunocompetent Patient on Septic ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AdministrateurDRC, University Hospital, Grenoble
- Investigators
- TIMSIT Jean FRANCOIS, PU/PH, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668329
- Sponsor's protocol ID
- 2009-A00822-55
- Acronym
- BIOSEPSIS
- Status last verified
- Aug 2012
- First submitted
- 8 Jul 2010
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-clinical Evolutive Dynamic in Patients Suffering From Communitary Septic Shock (Biosepsis)
- ClinicalTrials.gov ID
- NCT01668329
- Acronym / sponsor ID
- BIOSEPSIS / 2009-A00822-55
- Conditions
- Immunocompetent Patient on Septic Shock
- Keywords
- Septic shock, Inflammatory process, Cytokines, Hormonal response, Oxydative stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All immunocompetent patients hospitalised in intensive care from the beginning of the septic shock state.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- Minors
- Patient under guardianship or trusteeship
- Pregnant or lactating women
- Not affiliated to the social security
- Deprived of liberty by court decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evolutive profile of the inflammatory response during septic shock
Time frame: Hospitalisation in ICU
1 secondary outcome
Research for early prognosis factors
Time frame: Hospitalisation in ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TIMSIT Jean FRANCOIS, PU/PH principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunocompetent Patient on Septic Shock, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolutive profile of the inflammatory response during septic shock (time frame: Hospitalisation in ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2015.