NCT04055727

Brief Summary

A retrospective single-center study with patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years. The aim is to describe the association between adherence to treatment guidelines, gender, incidence and mortality for patients with sepsis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
11,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 7, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

November 12, 2021

Status Verified

November 1, 2021

Enrollment Period

3.5 years

First QC Date

August 12, 2019

Last Update Submit

November 11, 2021

Conditions

Sepsis

Keywords

treatment

Outcome Measures

Primary Outcomes (1)

  • Gender differences in 90-day mortality

    Gender differences in percentage of patients who died before day 90

    90 days

Secondary Outcomes (2)

  • Association between adherence to treatment guidelines and mortality

    90 days

  • Incidence of sepsis

    90 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to the emergency department at Södersjukhuset

You may qualify if:

  • Patients admitted to the Emergency Department at Södersjukhuset with suspicion of sepsis defined as blood cultures taken and intravenous antibiotics of type beta-lactam or aminoglycoside prescribed within 48 hours of admission.

You may not qualify if:

  • Patients transferred from other hospitals or treatment clinics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Södersjukhuset

Stockholm, 11880, Sweden

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Katarina Bohm, Ass Prof

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 14, 2019

Study Start

March 7, 2019

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

November 12, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)