NCT02875808

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2017

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

2.1 years

First QC Date

August 18, 2016

Last Update Submit

November 5, 2018

Conditions

Intrathecal InfectionExternal Ventricular Drainage Associated Infection

Outcome Measures

Primary Outcomes (1)

  • increasing IL-6, IL-8 and PCT prior to an clinically apparent intrathecal infection/ a detection with the goldstandard

    08/ 2014 - 12/ 2016

Study Arms (1)

patients

patients with an external ventricular drainage

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

consecutive patients with an external ventricular drainage

You may qualify if:

  • external ventricular drainage
  • informed consent

You may not qualify if:

  • no informed consent
  • prior intrathecal infection
  • prior systemic infection / sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery

Greifswald, 17475, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

cerebrospinal fluid and blood

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

August 18, 2016

First Posted

August 23, 2016

Study Start

August 1, 2014

Primary Completion

September 1, 2016

Study Completion

December 12, 2017

Last Updated

November 6, 2018

Record last verified: 2018-11

Locations

DE(1)