Acute Brain Injury, External Ventricular Drain, External Ventricular Drainage Associated Infection, Hydrocephalus
Conditions
Brief summary
This observational study involving patients with acute brain injury undergoing treatment with an external ventricular drain consists of three subprojects, aiming to: 1. investigate various biomarkers, with a primary focus on the development of cerebrospinal fluid lactate in relation to ventriculostomy-associated infection; 2. compare proximal and distal sample results obtained from an external ventricular drain; 3. describe the natural progression of various biomarkers in blood and cerebrospinal fluid following acute brain injury.
Interventions
As soon as possible after placement of the external drain, and then in intervals of 1-3 days; * CSF analyses: cerebrospinal fluid group analysis (eosinophilic granulocytes, erythrocytes, glucose, nucleated cells, leucocytes (mononuclear), lymphocytes, macrophages, monocytes, neutrophil granulocytes, protein, and smudge cells) and lactate (L-lactate and D-lactate). Analyses will be performed by the Dept. of Biochemistry, Rigshospitalet, Denmark. * CSF microscopy and culture: Analysed by the Dept. of Microbiology, Rigshospitalet, Denmark. * Blood: C-reactive protein, differentials (leukocytes, neutrophile granulocytes, erythrocytes, lymphocytes). Analyses will be performed by the Dept. of Biochemistry, Rigshospitalet, Denmark. * Blood: lactate and glucose. Point of care (POC) analysis by blood gas analyser (Radiometer ABL800 Series Flex Q, Denmark)
Sponsors
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * EVD in situ * Admission to the neuro-ICU or neurosurgical step-down unit at Rigshospitalet, Denmark * Diagnosis of acute brain injury categorized as traumatic brain injury, subarachnoid haemorrhage, intracranial haemorrage, intraventricular haemorrhage
Exclusion criteria
* Patient or closest relatives do not understand written and spoken Danish or English * Patients transferred to Rigshospitalet with an EVD * Patients with brain injury due to existing brain infection (e.g., meningitis, intracranial empyema or abscess, encephalitis) * Patients with existing ventriculoperitoneal or ventriculoatrial shunt at the time of admission * Patients with primary or secondary brain cancer * Patients died or in palliative care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of cerebrospinal fluid lactate | Throughout the external ventricular drain duration (1-60 days) | in patients with compared to patients without positive CSF culture, and for b. patients with both a positive CSF culture and a distinct drop in the level of consciousness compared to patients with negative CSF culture and a stable level of consciousness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CSF lactate concentration change in patients developing ventriculostomy associated infection | Throughout the external ventricular drain duration (1-60 days) | Concentration of CSF lactate and other CSF markers a. before, during and after detection of organisms in patients with a positive CSF culture, and b. if no organisms are detected, during the first, second and third tertile of EVD treatment. |
| Functional outcome at six months | 6 months after the initial brain injury | Functional outcome evaluated six months after the initial brain injury using: 1\) modified Rankin Scale (mRS) as favourable (0-2) or unfavourable (3-6) |
| Comparison of concentration of cerebrospinal fluid markers drawn from the proximal and distal port of the EVD | Throughout the external ventricular drain duration (1-60 days) | Mean difference, limits of agreement, intraclass correlation, mean of absolute difference and consistency between measurements of CSF markers drawn from the proximal and distal port of the EVD. |
Countries
Denmark
Contacts
CONTACTPernille Nielsen, Medical doctor
Outcome results
None listed