Detecting Sepsis in Patients With Severe Subarachnoideal Hemorrhage

March 14, 2022 updated by: Armin N. Flinspach, Goethe University
The study aims to evaluate the suitability of the SOFA score implemented by the Sepsis 3 guideline to detect sepsis in patients suffering from subrarachnoid hemorrhage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

58

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 Niederrad, Hessen, Germany, 60590
        • University Hospital Frankfurt

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with severe subarachnoid hemorrhage requiring intensive care.

Description

Inclusion Criteria:

Critically ill patients suffering from moderate to severe subarachnoid hemorrhage (WFNS >2).

Exclusion Criteria:

children under the age of 18 years Patients with minor subarachnoid hemorrhage < WFNS stage 2.

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: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sepsis SOFA positive
Time Frame: up to 2 months
Sepsis correctly detected by SOFA score (Sepsis-related organ failure assessment score, 0-24 points)
up to 2 months
Sepsis SOFA negative
Time Frame: up to 2 months
Sepsis not detected by SOFA score (Sepsis-related organ failure assessment score, 0-24 points)
up to 2 months

Collaborators and Investigators

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

Sponsor

Goethe University

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)

June 1, 2017

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (Actual)

February 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sepsis in SAH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The dataset will be published in an international journal. The data will be available upon reasonable request from the corresponding author

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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