Severe SepsisNCT01903746
Epidemiology of Septic Shock in Medical or Polyvalent ICU in the North-East Region of France
An observational study of Severe Sepsis and Persistent Hypotension, run by Centre Hospitalier Universitaire Dijon.
Trial summary
The epidemiology of this study aims and outcome of patients with septic shock in the intensive care unit (or versatile) of the North-East region in france as well as the modalities of care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Sepsis, Persistent Hypotension
- How many people
- 1,495 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Jan 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in septic shock
Who may be able to join
- Patients in septic shock defined by hypotension that is not reversed by volume resuscitation and requires the use of vasopressors.
Who cannot join
- None
About this study
The epidemiology of this study aims and outcome of patients with septic shock in the intensive care unit (or versatile) of the North-East region in france as well as the modalities of care.
- Conditions
- Severe Sepsis, Persistent Hypotension
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients in septic shock | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sequential Organ Failure Assessment
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startOct 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 1,495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jean pierre Quenot, Principal investigator, department Medical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903746
- Sponsor's protocol ID
- Quenot PHRC IR 2008
- Status last verified
- Jul 2013
- First submitted
- 17 Jul 2013
- Last updated
- 19 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Septic Shock in Medical or Polyvalent ICU in the North-East Region of France
- ClinicalTrials.gov ID
- NCT01903746
- Acronym / sponsor ID
- Quenot PHRC IR 2008
- Conditions
- Severe Sepsis, Persistent Hypotension
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 1,495 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 19 Jul 2013 (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.
The epidemiology of this study aims and outcome of patients with septic shock in the intensive care unit (or versatile) of the North-East region in france as well as the modalities of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in septic shock | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in septic shock
Key inclusion criteria (1 listed)
- Patients in septic shock defined by hypotension that is not reversed by volume resuscitation and requires the use of vasopressors.
Key exclusion criteria (1 listed)
- None
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
Sequential Organ Failure Assessment
Time frame: baseline
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
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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.
jean pierre Quenot principal investigator
department Medical Intensive Care
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis and Persistent Hypotension, run by Centre Hospitalier Universitaire Dijon.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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?
Sequential Organ Failure Assessment (time frame: baseline). 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 Jul 2013.