- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02875808
Cerebrospinal Fluid IL-6, IL-8 and PCT as Early Marker of an Intrathecal Infection in Neurosurgical Patients
November 5, 2018 updated by: Sascha Marx, University Medicine Greifswald
Early Detection of CSF Infection in Neurosurgical Patients
The value of CSF IL-6, IL-8 and Procalcitonin in detecting an early diagnosis of intrathecal infection in neurosurgical patients with an external ventricular drainage is evaluated.
Study Overview
Status
Completed
Detailed Description
The value of CSF IL-6, IL-8 and Procalcitonin in detecting an early diagnosis of intrathecal infection in neurosurgical patients with an external ventricular drainage is evaluated.
Study Type
Observational
Enrollment (Actual)
50
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
-
-
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Greifswald, Germany, 17475
- Department of Neurosurgery
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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
consecutive patients with an external ventricular drainage
Description
Inclusion Criteria:
- external ventricular drainage
- informed consent
Exclusion Criteria:
- no informed consent
- prior intrathecal infection
- prior systemic infection / sepsis
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: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
patients
patients with an external ventricular drainage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
increasing IL-6, IL-8 and PCT prior to an clinically apparent intrathecal infection/ a detection with the goldstandard
Time Frame: 08/ 2014 - 12/ 2016
|
08/ 2014 - 12/ 2016
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 1, 2014
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
December 12, 2017
Study Registration Dates
First Submitted
August 18, 2016
First Submitted That Met QC Criteria
August 22, 2016
First Posted (Estimate)
August 23, 2016
Study Record Updates
Last Update Posted (Actual)
November 6, 2018
Last Update Submitted That Met QC Criteria
November 5, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSF IL-6, IL-8 and PCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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