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Diagnostic Accuracy in Sepsis

Sponsor
Oslo University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03956043
Collaborator
(none)
1,000
Enrollment
1
Location
108
Anticipated Duration (Months)
9.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The sepsis syndrome has recently been more stringently defined as "a life-threatening organ dysfunction caused by a dysregulated host response to infection". Clinical and paraclinical tools are investigated for their ability to adequately recognize sepsis early.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Diagnostic Accuracy of Clinical and Paraclinical Tools in Sepsis
    Actual Study Start Date :
    May 15, 2017
    Anticipated Primary Completion Date :
    Sep 15, 2024
    Anticipated Study Completion Date :
    May 15, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with suspected sepsis in Emergency Department

    Patients with suspected sepsis treated by the sepsis emergency team or the medical emergency team in the Emergency Department of Oslo University Hospital Oslo are included prospectively.

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic accuracy in sepsis [within 90 days after inclusion]

      Sensitivity, specificity, predictive values, AUC of clinical criteria of sepsis in the Emergency department, compared to post hoc assesment

    2. Prognostic accuracy in sepsis [90 days after inclusion]

      Sensitivity, specificity, predictive values, AUC of clinical criteria of sepsis in the Emergency department, compared to in hospital, 30 and 90 days mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients >18 years old with suspected sepsis in the Emergency Department of Oslo University Hospital Oslo
    Exclusion Criteria:
    • Non

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oslo University Hospital Oslo Norway

    Sponsors and Collaborators

    • Oslo University Hospital

    Investigators

    • Principal Investigator: Aleksander R Holten, MD, PhD, Oslo University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aleksander Rygh Holten, Principal Investigator, Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT03956043
    Other Study ID Numbers:
    • Sepsis-OUH
    First Posted:
    May 20, 2019
    Last Update Posted:
    Apr 28, 2022
    Last Verified:
    Apr 1, 2022
    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
    Additional relevant MeSH terms:
    Sepsis
    Toxemia
    Systemic Inflammatory Response Syndrome

    Study Results

    No Results Posted as of Apr 28, 2022