SepsisqSOFA2NCT04568746
Implementation of a qSOFA Score in the Emergency Department
A study testing emergency vital room and box in people with Sepsis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The Quick-SOFA score (qSOFA), identifies septic patients with a mortality risk higher than 10%. In our study all adult patients coming to the emergency for suspected infection are screened according to the qSOFA score on arrival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- emergency vital room and box
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2020to 12 Nov 2021
- Phase
- Interventional
- 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
Who may be able to join
- body temperature below 36 °C or above 38 °C
- require hospitalization
Who cannot join
- hospital transfer,
- patients with pre hospital care
- language barrier,
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Implementation of a qSOFA Score on the Care of Adult Patients Referred to the Emergency Department for Suspected Infection
The Quick-SOFA score (qSOFA), identifies septic patients with a mortality risk higher than 10%. In our study all adult patients coming to the emergency for suspected infection are screened according to the qSOFA score on arrival. If qSOFA ≥ 2, the patient should be referred to emergency vital room, if the score <2, the patient will be in the box. The objectives are : 1) to evaluate the mortality at 28 days with the orientation, 2) to compare support time of medical contact and initiation of antibiotics according to the orientation in the emergency department.
- Conditions
- Sepsis
- Being tested
- emergency vital room, box
- Keywords
- screening, qSOFA, sepsis, Emergency care unit
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emergency vital roomProcedure or surgery
At the arrival of the patient, the qSOFA will be carried out to guide the orientation. Patient with score ≥ 2 will be supported in emergency vital room
boxProcedure or surgery
patient with score < 2 will be supported in box
| Study group | Role | What they receive |
|---|---|---|
| patients with qSOFA ≥ 2 | Other | adult patients with a qSOFA score ≥ 2 at the screening in the emergency department, will be referred to the emergency vital room Receives: Procedure: emergency vital room |
| patients with qSOFA <2 | Other | adult patients with a qSOFA score < 2 at the screening in the emergency department, will be referred to the box Receives: Procedure: box |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
compare mortality rate with orientation in emergency
Measured: 28 days
Secondary outcomes (2)
support time to medical contact
compare support time with orientation of patients according to the orientation of the patient in the emergency department
Measured: 1 day
support time to initiation of antibiotics
compare support time with initiation antibiotics of patients according to the orientation of the patient in the emergency department
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start12 Oct 2020
- Primary completion12 Oct 2021
- Study completion12 Nov 2021
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.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568746
- Sponsor's protocol ID
- P/2019/452
- Acronym
- qSOFA2
- Status last verified
- Jan 2025
- First submitted
- 24 Sep 2020
- Last updated
- 16 Jan 2025
- 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 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Implementation of a qSOFA Score on the Care of Adult Patients Referred to the Emergency Department for Suspected Infection
- ClinicalTrials.gov ID
- NCT04568746
- Acronym / sponsor ID
- qSOFA2 / P/2019/452
- Conditions
- Sepsis
- Keywords
- screening, qSOFA, sepsis, Emergency care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 29 Sep 2020 (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 Quick-SOFA score (qSOFA), identifies septic patients with a mortality risk higher than 10%. In our study all adult patients coming to the emergency for suspected infection are screened according to the qSOFA score on arrival. If qSOFA ≥ 2, the patient should be referred to emergency vital room, if the score <2, the patient will be in the box. The objectives are : 1) to evaluate the mortality at 28 days with the orientation, 2) to compare support time of medical contact and initiation of antibiotics according to the orientation in the emergency department.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with qSOFA ≥ 2 | Other | Procedure: emergency vital roomadult patients with a qSOFA score ≥ 2 at the screening in the emergency department, will be referred to the emergency vital room |
| patients with qSOFA <2 | Other | Procedure: boxadult patients with a qSOFA score < 2 at the screening in the emergency department, will be referred to the box |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- body temperature below 36 °C or above 38 °C
- require hospitalization
Key exclusion criteria (4 listed)
- hospital transfer,
- patients with pre hospital care
- language barrier,
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| emergency vital roomAt the arrival of the patient, the qSOFA will be carried out to guide the orientation. Patient with score ≥ 2 will be supported in emergency vital room | Procedure or surgery | patients with qSOFA ≥ 2 |
| boxpatient with score < 2 will be supported in box | Procedure or surgery | patients with qSOFA <2 |
Primary outcome
mortality rate
Time frame: 28 days
compare mortality rate with orientation in emergency
2 secondary outcomes
support time to medical contact
Time frame: 1 day
support time to initiation of antibiotics
Time frame: 1 day
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 16 Jan 2025.
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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?
A study testing emergency vital room and box in people with Sepsis, run by Centre Hospitalier Universitaire de Besancon 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 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: finished, as of the sponsor's last update on 16 Jan 2025. 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?
mortality rate (time frame: 28 days). 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 16 Jan 2025.