SepsisSARIEDNCT07020598
Sepsis Alert Routine Implementation in the Emergency Department
An observational study of Sepsis, run by Region Stockholm.
Trial summary
This study evaluates the impact of a structured sepsis alert routine, that has been implemented in the Emergency Department (ED) of Karolinska University Hospital Huddinge, Sweden. Using a retrospective cohort design, it compares patient outcomes before and after implementation of the routine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 3,389 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 31 Dec 2020
- How long will I take part?
- 90 Days
- 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: Adult patients presented at the Emergency Department with triage criteria for sepsis alert and antibiotic therapy initiated within 48 hours and continued for at least 96 hours or until death, discharge, ICU admission
Who may be able to join
- Age ≥18 years
- Admitted to hospital via the Emergency Department
- Fulfillment of sepsis alert triage criteria (per RETTS system)
- Antibiotic therapy initiated within 48 hours and continued ≥96 hours or until death/discharge/ICU transfer, as marker for suspected bacterial infection
Who cannot join
- Readmission within 28 days of a previous eligible admission
- No antimicrobial treatment
About this study
Official title: Effect of a Sepsis Alert Routine in the Emergency Department: A Before-and-After Cohort Study
This study evaluates the impact of a structured sepsis alert routine, that has been implemented in the Emergency Department (ED) of Karolinska University Hospital Huddinge, Sweden. Using a retrospective cohort design, it compares patient outcomes before and after implementation of the routine. The main aim is to assess whether the sepsis alert system improves 28-day mortality among patients with suspected sepsis.
Read the detailed description
Sepsis is a life-threatening condition associated with high morbidity and mortality, affecting millions of people globally each year. Timely recognition and early initiation of treatment are critical for improving outcomes. In response to this need, a structured sepsis alert routine was introduced in October 2017 at the Emergency Department (ED) of Karolinska University Hospital Huddinge, a large tertiary care hospital in Stockholm, Sweden.
The sepsis alert routine was designed to identify patients at risk of sepsis early in their ED visit, using predefined triage criteria. The alert was triggered by ED nurses based on suspected infection and specific triage parameters using the RETTS system (Rapid Emergency Triage and Treatment System). Patients with triage priority 1, or triage priority 2-3 combined with a blood lactate level of >3.2 mmol/L, were eligible. Once activated, a multidisciplinary response team-including physicians from the ED, Infectious Diseases, and Intensive Care Unit-was rapidly assembled to coordinate patient assessment and initiate early, protocolized sepsis care, including prompt antibiotic treatment and fluid resuscitation. The response followed a standardized checklist aligned with the Surviving Sepsis Campaign guidelines.
This study evaluates the clinical impact of the sepsis alert routine by comparing outcomes before and after its implementation. It uses a retrospective, observational cohort design with two data collection periods: a 2-year control period before the intervention (October 2015 - September 2017) and a 2.25-year period during which the sepsis alert was active (October 2017 - December 2019). All patients included were ≥18 years of age, admitted to hospital from the ED with suspected bacterial infection (defined by antibiotic therapy initiated within 48 hours and continued for at least 96 hours or until death, discharge, or ICU transfer), and met sepsis alert criteria.
To assess the effectiveness of the intervention, the primary outcome is 28-day all-cause mortality. Secondary outcomes include 90-day mortality, time to antibiotic administration, and length of hospital stay. Multivariable logistic regression will be used to analyze the full study population, with the intervention period (pre vs. post-implementation) as the main exposure variable, adjusting for covariates including sex, age, comorbidities (Charlson Comorbidity Index), SOFA score, triage priority, infection focus, body temperature, and do-not-resuscitate orders.
To further reduce confounding by indication, a propensity score matching analysis will be performed comparing patients who triggered the sepsis alert with matched historical controls. Propensity scores will be estimated using a logistic regression model including the aforementioned covariates as well as bacteremia status. Balance diagnostics and sensitivity analyses will be conducted to evaluate and account for any residual imbalances. Time-to-event outcomes will be analyzed using Kaplan-Meier survival curves.
This study will contribute important real-world data on the implementation of a sepsis alert system in a high-volume academic ED setting, and its potential to improve sepsis care and reduce mortality.
- Conditions
- Sepsis
- Keywords
- Sepsis, Emergency Department, Sepsis Alert, Antibiotics, Clinical Implementation, Mortality, Propensity Score Matching, Time to Treatment
- Medical subject headings
- Sepsis, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality
Death from any reason between presentation (day 0) to day 28
Measured: 28 days after presentation
Secondary outcomes (3)
90-day all-cause mortality
Death from any reason between presentation (day 0) and day 90
Measured: 90 days after presentation
Lenght of hospital stay
Duration from admission to discharge
Measured: From admission to discharge (up to 90 days after admission)
Time to first dose of antibiotics
Time from arrival in the Emergency Department to antibiotic administration
Measured: From arrival to antibiotic administration (up to 48 hours from arrival)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Oct 2015
- Primary completion29 Feb 2020
- Study completion31 Dec 2020
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
- Other
- Enrolment
- 3,389 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Kristoffer Strålin, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020598
- Sponsor's protocol ID
- 2017/1358-31
- Other IDs
- K 2017-2778
- Acronym
- SARIED
- Status last verified
- Jun 2025
- First submitted
- 30 May 2025
- Last updated
- 13 Jun 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 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Sepsis Alert Routine in the Emergency Department: A Before-and-After Cohort Study
- ClinicalTrials.gov ID
- NCT07020598
- Acronym / sponsor ID
- SARIED / 2017/1358-31
- Conditions
- Sepsis
- Keywords
- Sepsis, Emergency Department, Sepsis Alert, Antibiotics, Clinical Implementation, Mortality, Propensity Score Matching, Time to Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,389 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Jun 2025 (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.
This study evaluates the impact of a structured sepsis alert routine, that has been implemented in the Emergency Department (ED) of Karolinska University Hospital Huddinge, Sweden. Using a retrospective cohort design, it compares patient outcomes before and after implementation of the routine. The main aim is to assess whether the sepsis alert system improves 28-day mortality among patients with suspected sepsis.
Detailed description
Sepsis is a life-threatening condition associated with high morbidity and mortality, affecting millions of people globally each year. Timely recognition and early initiation of treatment are critical for improving outcomes. In response to this need, a structured sepsis alert routine was introduced in October 2017 at the Emergency Department (ED) of Karolinska University Hospital Huddinge, a large tertiary care hospital in Stockholm, Sweden.
The sepsis alert routine was designed to identify patients at risk of sepsis early in their ED visit, using predefined triage criteria. The alert was triggered by ED nurses based on suspected infection and specific triage parameters using the RETTS system (Rapid Emergency Triage and Treatment System). Patients with triage priority 1, or triage priority 2-3 combined with a blood lactate level of >3.2 mmol/L, were eligible. Once activated, a multidisciplinary response team-including physicians from the ED, Infectious Diseases, and Intensive Care Unit-was rapidly assembled to coordinate patient assessment and initiate early, protocolized sepsis care, including prompt antibiotic treatment and fluid resuscitation. The response followed a standardized checklist aligned with the Surviving Sepsis Campaign guidelines.
This study evaluates the clinical impact of the sepsis alert routine by comparing outcomes before and after its implementation. It uses a retrospective, observational cohort design with two data collection periods: a 2-year control period before the intervention (October 2015 - September 2017) and a 2.25-year period during which the sepsis alert was active (October 2017 - December 2019). All patients included were ≥18 years of age, admitted to hospital from the ED with suspected bacterial infection (defined by antibiotic therapy initiated within 48 hours and continued for at least 96 hours or until death, discharge, or ICU transfer), and met sepsis alert criteria.
To assess the effectiveness of the intervention, the primary outcome is 28-day all-cause mortality. Secondary outcomes include 90-day mortality, time to antibiotic administration, and length of hospital stay. Multivariable logistic regression will be used to analyze the full study population, with the intervention period (pre vs. post-implementation) as the main exposure variable, adjusting for covariates including sex, age, comorbidities (Charlson Comorbidity Index), SOFA score, triage priority, infection focus, body temperature, and do-not-resuscitate orders.
To further reduce confounding by indication, a propensity score matching analysis will be performed comparing patients who triggered the sepsis alert with matched historical controls. Propensity scores will be estimated using a logistic regression model including the aforementioned covariates as well as bacteremia status. Balance diagnostics and sensitivity analyses will be conducted to evaluate and account for any residual imbalances. Time-to-event outcomes will be analyzed using Kaplan-Meier survival curves.
This study will contribute important real-world data on the implementation of a sepsis alert system in a high-volume academic ED setting, and its potential to improve sepsis care and reduce mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presented at the Emergency Department with triage criteria for sepsis alert and antibiotic therapy initiated within 48 hours and continued for at least 96 hours or until death, discharge, ICU admission
Key inclusion criteria (4 listed)
- Age ≥18 years
- Admitted to hospital via the Emergency Department
- Fulfillment of sepsis alert triage criteria (per RETTS system)
- Antibiotic therapy initiated within 48 hours and continued ≥96 hours or until death/discharge/ICU transfer, as marker for suspected bacterial infection
Key exclusion criteria (2 listed)
- Readmission within 28 days of a previous eligible admission
- No antimicrobial treatment
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
28-day all-cause mortality
Time frame: 28 days after presentation
Death from any reason between presentation (day 0) to day 28
3 secondary outcomes
90-day all-cause mortality
Time frame: 90 days after presentation
Lenght of hospital stay
Time frame: From admission to discharge (up to 90 days after admission)
Time to first dose of antibiotics
Time frame: From arrival to antibiotic administration (up to 48 hours from arrival)
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 13 Jun 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Region Stockholm.
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 4 inclusion and 2 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 13 Jun 2025. 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?
28-day all-cause mortality (time frame: 28 days after presentation). 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 13 Jun 2025.