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Diagnostics of External Ventricular Drain Infections in Neurosurgical Patients

NCT04736407 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2021-02-03

No results posted yet for this study

Summary

External ventricular drains (EVD) are small tubes used in neuro-critical care inserted to measure pressure and treat acute build-up of fluid in the brain by draining the cerebrospinal fluid (CSF) in the ventricles, often following an event of traumatic or spontaneous bleeding. While essential to the care of these patients, EVDs run the risk of introducing bacteria into the brain of the patient, causing an EVD associated infection (EVDI). EVDIs are feared complications that are difficult to identify and predict in an intensive care setting. In order to allow for early identification of these infections, CSF is routinely sampled from the EVDs and its constitution analyzed for signs of infection. However, the constitution of the CSF in neuro-critical care patients are often difficult to assess as it is frequently mixed with blood that often clouds clinical decision making. No fast parameter has been found to yet reliably predict or identify these infections, resulting in excessive treatment with broad-spectrum antibiotics in this patient group.

EVDI diagnostics rely on mainly CSF analyses and cultures (growth of bacteria in the laboratory). Growing bacteria in the lab may take many days and can seldom guide early decision-making for these infections. Thus, EVDI diagnostics mainly rely on the analysis of the CSF constitution. Many diagnostic criteria rely on the relationship between white and red blood cells in the CSF, with red blood cells being introduced in the CSF following the brain bleed , and white blood cells being seen as a response to infection. These criteria assume that the blood is homogeneous in the CSF. However, from computed tomography (CT) imaging of these patients, it is seen that blood can settle in the brain ventricles.

In this study we aim to test the assumption that blood is homogeneously distributed in the CSF by sampling from the CSF in patients. Two samples are serially drawn allocated to a period between where patients are planned for a clinical repositioning, or not. We hypothesise that a heterogeneous distribution of blood in the CSF (as seen on CT imaging) may allow for the CSF constitution to change in serially drawn CSF samples, and that these changes may be exacerbated in repositioned patients as it may disturb the blood that has settled at the bottom of the ventricles as a result of gravity sedimentation. We further believe that these changes may affect clinical decision making and further complicate EVDI diagnostics.

Conditions

  • Ventriculitis, Cerebral

Interventions

OTHER

Observational sampling of CSF timed around routine clinical repositioning, or not

no true intervention

Sponsors & Collaborators

  • Region Stockholm

    collaborator OTHER_GOV

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • David W Nelson, MD,PhD · Karolinska University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-05
Primary Completion
2019-04-26
Completion
2019-04-26

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04736407 on ClinicalTrials.gov