CSF lactate and other biomarkers in patients with an external ventricular drain after acute brain injury
Official title: CSF Lactate and Ventriculostomy Associated Infections in Patients With Acute Brain Injury - a Prospective, Observational Cohort Study.
Run by Copenhagen University Hospital, Rigshospitalet · NCT07380477 · Data updated 2026-11-12
This project will test whether changes in cerebrospinal fluid lactate and other blood/CSF biomarkers can help detect ventriculostomy-associated infection in adults with acute brain injury who have an external ventricular drain.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 148 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | January 15, 2025 |
| Main results expected | January 15, 2027 |
| Study ends | October 1, 2029 |
| Registry record updated | February 2, 2026 |
| Trial ID | NCT07380477 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 admitted to the neuro-ICU or neurosurgical step-down at Rigshospitalet with an EVD placed for acute brain injury (traumatic brain injury, subarachnoid hemorrhage, intracerebral or intraventricular hemorrhage) and who understand Danish or English.
✕Probably not a fit
Patients transferred to Rigshospitalet with an existing EVD, those with preexisting brain infection, ventriculoperitoneal/ventriculoatrial shunts, primary/secondary brain cancer, or those in palliative care or deceased are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational cohort project at Rigshospitalet enrolling adults with acute brain injury who have an external ventricular drain (EVD) in place. Researchers will collect serial cerebrospinal fluid (CSF) and blood samples from the EVD and compare biomarker levels over time. The work consists of three subprojects: tracking CSF lactate in relation to ventriculostomy-associated infection, comparing proximal versus distal EVD sample results, and describing natural biomarker trajectories after injury. No experimental treatments are given; data are used to refine diagnostic understanding and sampling practices.
Why it matters
Potential benefit: If successful, the findings could enable earlier or more accurate detection of EVD-related infections and help guide clinical decisions about treatment or drainage management.
How similar studies have gone: Previous studies have shown that CSF lactate and serial biomarker monitoring can aid in diagnosing central nervous system infections but results have been variable, so this project builds on existing evidence to refine sampling location and timing.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Rigshospitalet
Copenhagen, Denmark Recruiting
Study contacts
- Study coordinator: Pernille Nielsen, Medical doctor
- Email: pernille.nielsen.05@regionh.dk
- Phone: +45 22220775
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.