About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with acute brain injury, that are treated with an external ventricular drain
Trial design
Cohort
Prospective
Treatments tested in this trial
Sampling of blood and cerebrospinal fluid
Other interventionAs 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)
Treatment groups
Trial outcomes
Primary outcomes
Concentration of cerebrospinal fluid lactate
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 outcomes
CSF lactate concentration change in patients developing ventriculostomy associated infection
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
Functional outcome evaluated six months after the initial brain injury using: 1\) modified Rankin Scale (mRS) as favourable (0-2) or unfavourable (3-6)
Functional outcome at six months
Functional outcome evaluated six months after the initial brain injury using: 2\) Glascow Outcome Score-Extended (GOS-E) as favorable (5-8) or unfavorable (0-4)
Comparison of concentration of cerebrospinal fluid markers drawn from the proximal and distal port of the EVD
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.
Sponsors and contacts
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