Diagnostics of External Ventricular Drain Infections in Neurosurgical Patients

NCT04736407 | Completed

• 1 other identifier: 2017-3456
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

External ventricular drain; Infection; cell count

Outcome Measures

Primary Outcomes (2)

• Suspected infection

  Changes in diagnostic group following standard diagnostic criteria

  10 minutes

• CSF cell count changes between paired samples

  CSF parameter differences and variability between paired samples

  10 minutes

Secondary Outcomes (1)

• Other diagnostic parameters

  10 minutes

Study Arms (2)

Repositioned

Allocated to sampling performed around a standard clinical repositioning (lateral side to side), or a 10 minute wait period between two serially drawn CSF samples, for each biweekly routine CSF infection surveillance sampling.

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

Non-repositioned

Allocated to sampling performed with a 10 minute wait period between two serially drawn CSF samples, for each biweekly routine CSF infection surveillance sampling

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

Interventions

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

no true intervention

Non-repositioned; Repositioned

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Neuro Intensive Care patients in University Hospital Setting. This is the only NICU unit in the Stockholm region and covers the full population requiring ICU care with EVDs in the area

You may not qualify if:

• patients admitted with bacterial or viral CNS infections

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Region Stockholm: collaborator

Study Sites (1)

Function Preoperative Medicine and Intensive Care, Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (1)

• Badholm M, Blixt J, Glimaker M, Ternhag A, Hedlund J, Nelson DW. Cerebrospinal fluid cell count variability is a major confounding factor in external ventricular drain-associated infection surveillance diagnostics: a prospective observational study. Crit Care. 2021 Aug 11;25(1):291. doi: 10.1186/s13054-021-03715-1.

  PMID: 34380543 DERIVED

MeSH Terms

Conditions

Cerebral Ventriculitis; Infections

Condition Hierarchy (Ancestors)

Central Nervous System Viral Diseases; Central Nervous System Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• David W Nelson, MD,PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Research Group Leader

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: October 5, 2017
• Primary Completion: April 26, 2019
• Study Completion: April 26, 2019
• Last Updated: February 3, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)