SepsisTriageNCT04913246
Triage Score VS Quick-Sofa Score in Septic Patients in the Emergency Department
An observational study of Sepsis and Emergencies, run by Hôpital Universitaire Sahloul.
Trial summary
Sepsis represents by its frequency, its morbidity and mortality and its cost to society a major public health issue with a constantly increasing incidence. It affects millions of people around the world each year and is the 2nd leading cause of death in intensive care units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Emergencies
- How many people
- 430 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2014to 31 Mar 2019
- How long will I take part?
- 1 Year
- 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: each patient diagnosed as an acute Sepsi consulting the emergencies of CHU Sahloul, Sousse
Who may be able to join
- Age >18 years old
- each patient diagnosed as an acute Sepsi consulting the emergencies of CHU Sahloul, Sousse
Who cannot join
- no exclusion
About this study
Official title: Comparison of the Triage Score With the Quick-Sofa Score (qSofa) in Septic Patients in the Emergency Department: Diagnostic and Prognostic Value.
Sepsis represents by its frequency, its morbidity and mortality and its cost to society a major public health issue with a constantly increasing incidence. It affects millions of people around the world each year and is the 2nd leading cause of death in intensive care units.
The incidence of sepsis has been estimated by the World Health Organization (WHO), based on US data, at 15 to 19 million cases of sepsis per year worldwide.
Read the detailed description
This is a descriptive, mono-center study aimed at comparing a local triage score with that of qsofa in patients presenting to the Sahloul Emergency Department with sepsis.
A local triage score was calculated for each patient consulting the emergency room; this score makes it possible to classify patients according to severity and to predict the time to treatment.
A form is completed prospectively for each patient admitted to the observation unit whose diagnosis of sepsis is confirmed and validated by a senior during the morning staff.
The validated data were included in the ReSSUS register (Sepsis Register of the Sahloul Emergency Department). This is an observational database on the management of sepsis admitted to the emergency department in Sahloul. It ensures a high level of confidentiality and protection of medical data.
Subsequent follow-up of patients was done by telephone contact to verify mortality at one month and one year.
- Conditions
- Sepsis, Emergencies
- Keywords
- Sepsis, severity, prognosis, triage, Mortalty
- Medical subject headings
- Sepsis, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: one month
Secondary outcomes (1)
Mortality and /or readmission
Mortality and /or readmission
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start1 Mar 2014
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
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
- 430 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Sahloul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riadh Boukef, Hôpital Universitaire Sahloul
- Investigators
- Riadh Boukef, professor, Principal investigator, CHU Sahloul, Sousse, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913246
- Sponsor's protocol ID
- Triage-Sepsis
- Acronym
- Triage
- Status last verified
- Jan 2023
- First submitted
- 25 May 2021
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Triage Score With the Quick-Sofa Score (qSofa) in Septic Patients in the Emergency Department: Diagnostic and Prognostic Value.
- ClinicalTrials.gov ID
- NCT04913246
- Acronym / sponsor ID
- Triage / Triage-Sepsis
- Conditions
- Sepsis, Emergencies
- Keywords
- Sepsis, severity, prognosis, triage, Mortalty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Hôpital Universitaire SahloulUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 4 Jun 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 represents by its frequency, its morbidity and mortality and its cost to society a major public health issue with a constantly increasing incidence. It affects millions of people around the world each year and is the 2nd leading cause of death in intensive care units.
The incidence of sepsis has been estimated by the World Health Organization (WHO), based on US data, at 15 to 19 million cases of sepsis per year worldwide.
Detailed description
This is a descriptive, mono-center study aimed at comparing a local triage score with that of qsofa in patients presenting to the Sahloul Emergency Department with sepsis.
A local triage score was calculated for each patient consulting the emergency room; this score makes it possible to classify patients according to severity and to predict the time to treatment.
A form is completed prospectively for each patient admitted to the observation unit whose diagnosis of sepsis is confirmed and validated by a senior during the morning staff.
The validated data were included in the ReSSUS register (Sepsis Register of the Sahloul Emergency Department). This is an observational database on the management of sepsis admitted to the emergency department in Sahloul. It ensures a high level of confidentiality and protection of medical data.
Subsequent follow-up of patients was done by telephone contact to verify mortality at one month and one year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- each patient diagnosed as an acute Sepsi consulting the emergencies of CHU Sahloul, Sousse
Key inclusion criteria (2 listed)
- Age >18 years old
- each patient diagnosed as an acute Sepsi consulting the emergencies of CHU Sahloul, Sousse
Key exclusion criteria (1 listed)
- no exclusion
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
Mortality
Time frame: one month
1 secondary outcome
Mortality and /or readmission
Time frame: one year
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 4 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Sepsis
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.
Riadh Boukef, professor principal investigator
CHU Sahloul, Sousse, Tunisia
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Emergencies, run by Hôpital Universitaire Sahloul.
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 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: finished, as of the sponsor's last update on 4 Jan 2023. 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 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 (time frame: one month). 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 4 Jan 2023.