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Evaluation of qSOFA in Neurosurgical Patients

Sponsor
Goethe University (Other)
Overall Status
Completed
CT.gov ID
NCT04265404
Collaborator
(none)
100
Enrollment
1
Location
14.4
Actual Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to look if Quick Sequential Organ Failure Assessment Score score in detecting a eary Sepsis is afflicted by neurosurgical disorders

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Prospective Evaluation of qSOFA (Quick Sequential Organ Failure Assessment Score) to Detect Systemic Infection in Neurosurgical Patients
    Actual Study Start Date :
    Aug 20, 2018
    Actual Primary Completion Date :
    Aug 20, 2019
    Actual Study Completion Date :
    Oct 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Baseline measurement of qSOFA at admission to ICU [Measurement at the time of admission to the intensive care unit]

      assessment of qSOFA (Quick Sequential Organ Failure Assessment Score)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: one of the following diseases

    • Subarachnoidal Bleeding

    • Traumatic brain injury

    • Spondylodiszitis

    Exclusion Criteria:

    • intubated before income

    • Age under 16

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johann Wolfgang Goethe Universität Frankfurt Hessen Germany 60598

    Sponsors and Collaborators

    • Goethe University

    Investigators

    • Principal Investigator: Jürgen Konczalla, Prof., Johann Wolfgang Goethe Universität

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elisabeth H. Adam, Principal Investigator, Goethe University
    ClinicalTrials.gov Identifier:
    NCT04265404
    Other Study ID Numbers:
    • 75/18
    First Posted:
    Feb 11, 2020
    Last Update Posted:
    Feb 11, 2020
    Last Verified:
    Feb 1, 2020
    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:
    Brain Injuries
    Subarachnoid Hemorrhage
    Brain Injuries, Traumatic
    Hemorrhage

    Study Results

    No Results Posted as of Feb 11, 2020