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Sepsis: From Syndrome to Personalized Care

Sponsor
Oslo University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04203979
Collaborator
(none)
450
Enrollment
1
Location
35.8
Anticipated Duration (Months)
12.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, observational study designed to examine the performance of biomarkers, molecular biological methods and other analysis in blood from patient with suspected sepsis in the Emergency department. 300 - 400 patients will be enrolled.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study will prospectively include adult patients (>18 years) with suspected sepsis admitted to Oslo University Hospital, Ullevål (OUH-Ullevål). Patients admitted to the emergency department and managed by the medical rapid response team or the sepsis rapid response team are considered eligible for inclusion. Informed consent will be collected at the emergency department if possible, or within few days, by a clinical investigator or a study nurse. The investigators aim to include 300 - 400 patients treated by the Sepsis Rapid Response Team or Medical Emergency team for possible sepsis. Patients classified to have had other conditions than sepsis in the post hoc assessment will be used as controls. The inclusion period will be 12 months.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    450 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Sepsis: From Syndrome to Personalized Care
    Actual Study Start Date :
    Jan 6, 2020
    Actual Primary Completion Date :
    Dec 31, 2020
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Number of sepsis patient with elevated plasma-calprotectin [One year]

      Sensitivity of plasma-calprotectin for detecting infections in critical ill medical patients in the Emergency department.

    2. Area under the curve receiver operator characteristic (AUC - ROC) for inflammation biomarkers for detecting infection in critically ill patients. [One year]

      Comparing area under the curve receiver operator characteristic (AUC - ROC) for calprotectin, pro-calcitonin, CRP and other biomarkers for detecting infections in critically ill patients in the Emergency department.

    3. Number of sepsis patient with bacterial DNA detected in blood by molecular biological tests. [One year]

      The performance of rapid molecular biological tests for detecting bacterial DNA in full blood in critically ill medical patients, compared to current state-of-the art diagnostics (blood culture).

    Secondary Outcome Measures

    1. Concentration of biomarkers in blood. [One year]

      Explore how the concentration of biomarkers of inflammation change during the course of the disease.

    Eligibility Criteria

    Criteria

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

    • admitted to emergency department OUH, Ullevål.

    • managed by the medical rapid response team or the sepsis rapid response team

    Exclusion Criteria:
    • Not given informed consent by patient or next of kin (if patient is not able to)

    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, 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:
    NCT04203979
    Other Study ID Numbers:
    • Sepsis-OUH-2
    First Posted:
    Dec 18, 2019
    Last Update Posted:
    Sep 10, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sepsis
    Toxemia
    Syndrome
    Systemic Inflammatory Response Syndrome

    Study Results

    No Results Posted as of Sep 10, 2021