Sepsis at Södersjukhuset-Adherence to Treatment Guidelines

Sponsor
Karolinska Institutet (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04055727
Collaborator
(none)
11,000
1
41.9
262.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In this single-center study, patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years will be included. About 11,000 patients will be included. Patient data including described sepsis symptoms will be drawn from the electronic medical record, TakeCare and Clinisoft. Logistic regression analysis will adjust for age, gender, comorbidity according to Charlson score, vital signs, with preliminary focus of infection (pneumonia, urinary tract infection, abdominal, other, unknown). The Surviving Sepsis guidelines for the time period are: 3-hour bundle including lactate measurement, obtaining blood culture, fluid treatment if hypotensive and administration of broad-spectrum antibiotics. The 6-hour bundles with administration of vasopressors if needed, remeasure lactate if elevated, with persistent hypotension re-asses volume status and tissue perfusion. Time zero is defined as the admission time to the emergency department. The aim is to describe the association between adherence to treatment guidelines, gender, incidence and mortality for patients with sepsis.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    11000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Sepsis at Södersjukhuset-Adherence to Treatment Guidelines
    Actual Study Start Date :
    Mar 7, 2019
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Gender differences in 90-day mortality [90 days]

      Gender differences in percentage of patients who died before day 90

    Secondary Outcome Measures

    1. Association between adherence to treatment guidelines and mortality [90 days]

      Association between number of completed sepsis bundles and mortality

    2. Incidence of sepsis [90 days]

      Number of patients admitted to the Emergency Department at Södersjukhuset during the study period comparing to the hospitals catchment area

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • 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.

    Exclusion criteria:

    • Patients transferred from other hospitals or treatment clinics.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Södersjukhuset Stockholm Sweden 11880

    Sponsors and Collaborators

    • Karolinska Institutet

    Investigators

    • Principal Investigator: Katarina Bohm, Ass Prof, Karolinska Institutet

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Katarina Bohm, Associate Professor, Karolinska Institutet
    ClinicalTrials.gov Identifier:
    NCT04055727
    Other Study ID Numbers:
    • SepsisSoS
    First Posted:
    Aug 14, 2019
    Last Update Posted:
    Nov 12, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Katarina Bohm, Associate Professor, Karolinska Institutet
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 12, 2021