Evaluation of qSOFA in Neurosurgical Patients

February 8, 2020 updated by: Elisabeth H. Adam, Goethe University

Prospective Evaluation of qSOFA (Quick Sequential Organ Failure Assessment Score) to Detect Systemic Infection in Neurosurgical Patients

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60598
        • Johann Wolfgang Goethe Universität

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients brought to the ICU with Inclusion Citeria.

Description

Inclusion Criteria: one of the following diseases

  • Subarachnoidal Bleeding
  • Traumatic brain injury
  • Spondylodiszitis

Exclusion Criteria:

  • intubated before income
  • Age under 16

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline measurement of qSOFA at admission to ICU
Time Frame: Measurement at the time of admission to the intensive care unit
assessment of qSOFA (Quick Sequential Organ Failure Assessment Score)
Measurement at the time of admission to the intensive care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goethe University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2018

Primary Completion (Actual)

August 20, 2019

Study Completion (Actual)

October 31, 2019

Study Registration Dates

First Submitted

October 16, 2019

First Submitted That Met QC Criteria

February 8, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 8, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 75/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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