Severe Septic SyndromeCASCNCT03280992
Community Acquired Sepsis Cohort
An observational study of Severe Septic Syndrome and Septic Shock, run by Rennes University Hospital at 1 site in France.
Trial summary
The aim of this project is to constitute a prospective cohort of all the patients presenting to the adult emergencies of the University Hospital Centre (CHU) of Rennes for a septic syndrome of community origin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Septic Syndrome, Septic Shock
- How many people
- 796 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2016to 27 Aug 2018
- How long will I take part?
- 3 Months
- 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: Patient with a community infectious diseases
Who may be able to join
- Patient older than 18 years old
- Patient hospitalized during the study period for community infectious diseases at the CHU of Rennes
Who cannot join
- Written objection from the patient to the computer processing of his data
- Pregnant women
- Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this project is to constitute a prospective cohort of all the patients presenting to the adult emergencies of the University Hospital Centre (CHU) of Rennes for a septic syndrome of community origin.
Read the detailed description
Severe septic syndrome (SSG) and septic shock (CS) are two frequent and serious complications of infectious diseases. In this context, the optimization of the management of septic patients from their reception in the emergency services must be a priority. However there are no predictors of progression or severity in patients admitted to emergencies despite the recommendations emphasizing the need for screening and early therapeutic management. Many scores have been proposed for intensive care unit but they remain difficult to extrapolate to other services because they are very comprehensive and require information that is difficult to obtain for emergency physicians.
- Conditions
- Severe Septic Syndrome, Septic Shock
- Medical subject headings
- Toxemia, Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of morbidity in patients with septic syndrome of community origin
Study of prognostic factors
Measured: Day 90
Internal validity, severity score
Measured: Day 90
Internal validity, triage score by orientation nurses
Measured: Day 90
Study of the prognostic factors of patients with septic syndrome of community origin in terms of mortality
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start2 Mar 2016
- Primary completion27 Aug 2018
- Study completion27 Aug 2018
Why it stopped: Study not feasible in practise
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Septic SyndromeStudies of the same condition, open and under way.
- 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
- 796 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280992
- Sponsor's protocol ID
- 35RC16_3024_CASC
- Acronym
- CASC
- Status last verified
- Dec 2021
- First submitted
- 18 Aug 2017
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Acquired Sepsis Cohort
- ClinicalTrials.gov ID
- NCT03280992
- Acronym / sponsor ID
- CASC / 35RC16_3024_CASC
- Conditions
- Severe Septic Syndrome, Septic Shock
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study not feasible in practise
- Enrolment
- 796 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 13 Sep 2017 (actual)
- 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 aim of this project is to constitute a prospective cohort of all the patients presenting to the adult emergencies of the University Hospital Centre (CHU) of Rennes for a septic syndrome of community origin.
Detailed description
Severe septic syndrome (SSG) and septic shock (CS) are two frequent and serious complications of infectious diseases. In this context, the optimization of the management of septic patients from their reception in the emergency services must be a priority. However there are no predictors of progression or severity in patients admitted to emergencies despite the recommendations emphasizing the need for screening and early therapeutic management. Many scores have been proposed for intensive care unit but they remain difficult to extrapolate to other services because they are very comprehensive and require information that is difficult to obtain for emergency physicians.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a community infectious diseases
Key inclusion criteria (2 listed)
- Patient older than 18 years old
- Patient hospitalized during the study period for community infectious diseases at the CHU of Rennes
Key exclusion criteria (3 listed)
- Written objection from the patient to the computer processing of his data
- Pregnant women
- Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
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
Assessment of morbidity in patients with septic syndrome of community origin
Time frame: Day 90
Study of prognostic factors
Internal validity, severity score
Time frame: Day 90
Internal validity, triage score by orientation nurses
Time frame: Day 90
Study of the prognostic factors of patients with septic syndrome of community origin in terms of mortality
Time frame: Day 90
Results and safety
The study was stopped early (reason given: Study not feasible in practise). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Severe Septic Syndrome and Septic Shock, run by Rennes University Hospital 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 2 inclusion and 3 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 2 Dec 2021. 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 was stopped early (reason given: Study not feasible in practise). 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?
Assessment of morbidity in patients with septic syndrome of community origin (time frame: Day 90). The study lists 4 primary outcomes in all. 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 2 Dec 2021.