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SepsisSARIEDNCT07020598

Sepsis Alert Routine Implementation in the Emergency Department

An observational study of Sepsis, run by Region Stockholm.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

  1. 28-day all-cause mortality

    Death from any reason between presentation (day 0) to day 28

    Measured: 28 days after presentation

Secondary outcomes (3)
  1. 90-day all-cause mortality

    Death from any reason between presentation (day 0) and day 90

    Measured: 90 days after presentation

  2. Lenght of hospital stay

    Duration from admission to discharge

    Measured: From admission to discharge (up to 90 days after admission)

  3. 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.

  1. First posted13 Jun 2025
  2. Study start1 Oct 2015
  3. Primary completion29 Feb 2020
  4. Study completion31 Dec 2020

Resources

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
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

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.

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SARIED Clinical Trial NCT07020598 | AzTrials