SepsisCIPRES-EDNCT04803942
Clinical Intuition for PRedicting Evolution in Sepsis in the Emergency Department - CIPRES-ED Study
An observational study of Sepsis, run by Centre Hospitalier le Mans at 1 site in France.
Trial summary
Sepsis is a syndrome involving infection and an abnormal systemic inflammatory response in the infected organism, resulting in organ dysfunction and possibly death. It is a major cause of hospital mortality. A large proportion of sepsis diagnoses are made in emergency departments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 692 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2021to 31 Oct 2022
- 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: Patients presenting to one of the participating emergency departments with suspected infection
Who may be able to join
- Patients presenting to one of the participating emergency departments with suspected infection, defined as the presence of at least one of these parameters:
- Temperature ≥ 38°C ou < 36°C measured in the emergency room Chills (in the emergency room or on recent history)
- No objection to participation in the study
Who cannot join
- Minor patient (<18 years)
- Patient under guardianship or other protective measure
- Patient unable to understand research information
- Patient refusing the use of their data for research purposes
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Du Mans
Le Mans, 72000
Christelle JADEAU, 02 44 71 07 81, cjadeau@ch-lemans.fr
About this study
Sepsis is a syndrome involving infection and an abnormal systemic inflammatory response in the infected organism, resulting in organ dysfunction and possibly death. It is a major cause of hospital mortality. A large proportion of sepsis diagnoses are made in emergency departments. Early diagnosis and appropriate treatment have been shown to reduce mortality from this disease.
In a context of limited resources, it is therefore important to be able to quickly stratify patients presenting to the emergency department with a suspected infection into those who require rapid and intensive management because they are at risk of developing sepsis and septic shock and those who can be managed conventionally The objective of this study is to compare the clinical intuition of emergency room physicians and nurses with the qSOFA score to predict the clinical course of patients presenting to the emergency room with potential sepsis.
- Conditions
- Sepsis
- Keywords
- Sepsis, clinical intuition, emergency department
- Medical subject headings
- Sepsis, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare emergency physicians' clinical intuition versus qSOFA score for prediction of 30-day mortality in patients with suspected infection
We compare the area under the ROC curve of each test (Emergency physicians' clinical intuition versus qSOFA score) to predict 30-day mortality in patients with suspected infection
Measured: 1 month after inclusion
Secondary outcomes (1)
Compare emergency physicians' clinical intuition versus qSOFA score for prediction of 72 hours mortality in patients with suspected infection
We compare the area under the ROC curve of each test (Emergency physicians' clinical intuition versus qSOFA score) to predict 72 hours mortality in patients with suspected infection
Measured: 72 hours after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start19 Jan 2021
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- 692 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803942
- Sponsor's protocol ID
- CHM-2020/S2/06
- Acronym
- CIPRES-ED
- Status last verified
- Mar 2021
- First submitted
- 15 Mar 2021
- Last updated
- 18 Mar 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 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Intuition for PRedicting Evolution in Sepsis in the Emergency Department - CIPRES-ED Study
- ClinicalTrials.gov ID
- NCT04803942
- Acronym / sponsor ID
- CIPRES-ED / CHM-2020/S2/06
- Conditions
- Sepsis
- Keywords
- Sepsis, clinical intuition, emergency department
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 692 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 18 Mar 2021 (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.
Sepsis is a syndrome involving infection and an abnormal systemic inflammatory response in the infected organism, resulting in organ dysfunction and possibly death. It is a major cause of hospital mortality. A large proportion of sepsis diagnoses are made in emergency departments. Early diagnosis and appropriate treatment have been shown to reduce mortality from this disease.
In a context of limited resources, it is therefore important to be able to quickly stratify patients presenting to the emergency department with a suspected infection into those who require rapid and intensive management because they are at risk of developing sepsis and septic shock and those who can be managed conventionally The objective of this study is to compare the clinical intuition of emergency room physicians and nurses with the qSOFA score to predict the clinical course of patients presenting to the emergency room with potential sepsis.
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
- Patients presenting to one of the participating emergency departments with suspected infection
Key inclusion criteria (3 listed)
- Patients presenting to one of the participating emergency departments with suspected infection, defined as the presence of at least one of these parameters:
- Temperature ≥ 38°C ou < 36°C measured in the emergency room Chills (in the emergency room or on recent history)
- No objection to participation in the study
Key exclusion criteria (4 listed)
- Minor patient (<18 years)
- Patient under guardianship or other protective measure
- Patient unable to understand research information
- Patient refusing the use of their data for research purposes
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
Compare emergency physicians' clinical intuition versus qSOFA score for prediction of 30-day mortality in patients with suspected infection
Time frame: 1 month after inclusion
We compare the area under the ROC curve of each test (Emergency physicians' clinical intuition versus qSOFA score) to predict 30-day mortality in patients with suspected infection
1 secondary outcome
Compare emergency physicians' clinical intuition versus qSOFA score for prediction of 72 hours mortality in patients with suspected infection
Time frame: 72 hours after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 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.
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 Sepsis, run by Centre Hospitalier le Mans 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christelle JADEAU (02 44 71 07 81, cjadeau@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare emergency physicians' clinical intuition versus qSOFA score for prediction of 30-day mortality in patients with suspected infection (time frame: 1 month after inclusion). 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 18 Mar 2021.