NCT07020598

Brief 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. The main aim is to assess whether the sepsis alert system improves 28-day mortality among patients with suspected sepsis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,389

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

4.4 years

First QC Date

May 30, 2025

Last Update Submit

June 10, 2025

Conditions

Sepsis

Keywords

SepsisEmergency DepartmentSepsis AlertAntibioticsClinical ImplementationMortalityPropensity Score MatchingTime to Treatment

Outcome Measures

Primary Outcomes (1)

  • 28-day all-cause mortality

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

    28 days after presentation

Secondary Outcomes (3)

  • 90-day all-cause mortality

    90 days after presentation

  • Lenght of hospital stay

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

  • Time to first dose of antibiotics

    From arrival to antibiotic administration (up to 48 hours from arrival)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • Readmission within 28 days of a previous eligible admission
  • No antimicrobial treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SepsisEmergencies

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
90 Days
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Senior Consultant

Study Record Dates

First Submitted

May 30, 2025

First Posted

June 13, 2025

Study Start

October 1, 2015

Primary Completion

February 29, 2020

Study Completion

December 31, 2020

Last Updated

June 13, 2025

Record last verified: 2025-06