VentricuLostomy AssoCiaTed InfeCtions (LACTIC): Focus on CSF Lactate and Sampling Site
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sampling of blood and cerebrospinal fluid.
- Who it may be relevant to
- Registry conditions: Acute Brain Injury, Hydrocephalus, External Ventricular Drain, External Ventricular Drainage Associated Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
CSF Lactate and Ventriculostomy Associated Infections in Patients With Acute Brain Injury - a Prospective, Observational Cohort Study.
Overview
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
- Other Sampling of blood and cerebrospinal fluid
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
Primary outcome measures
- Concentration of cerebrospinal fluid lactate [Time frame: Throughout the external ventricular drain duration (1-60 days)]
Secondary outcome measures (4)
- CSF lactate concentration change in patients developing ventriculostomy associated infection [Time frame: Throughout the external ventricular drain duration (1-60 days)]
- Functional outcome at six months [Time frame: 6 months after the initial brain injury]
- Functional outcome at six months [Time frame: 6 months after the initial brain injury]
- Comparison of concentration of cerebrospinal fluid markers drawn from the proximal and distal port of the EVD [Time frame: Throughout the external ventricular drain duration (1-60 days)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Rigshospitalet — Copenhagen
Identifiers
NCT: NCT07380477 · H-24051777 · p-2024-17691