Acute Brain InjuryLACTICNCT07380477
VentricuLostomy AssoCiaTed InfeCtions (LACTIC): Focus on CSF Lactate and Sampling Site
An observational study of Acute Brain Injury and Hydrocephalus, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Brain Injury, Hydrocephalus, External Ventricular Drain
- What is being tested?
- Sampling of blood and cerebrospinal fluid
- How many people
- 148 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2025to 1 Oct 2029
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute brain injury, that are treated with an external ventricular drain
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: CSF Lactate and Ventriculostomy Associated Infections in Patients With Acute Brain Injury - a Prospective, Observational Cohort Study.
This observational study involving patients with acute brain injury undergoing treatment with an external ventricular drain consists of three subprojects, aiming to:
- investigate various biomarkers, with a primary focus on the development of cerebrospinal fluid lactate in relation to ventriculostomy-associated infection;
- compare proximal and distal sample results obtained from an external ventricular drain;
- describe the natural progression of various biomarkers in blood and cerebrospinal fluid following acute brain injury.
- Conditions
- Acute Brain Injury, Hydrocephalus, External Ventricular Drain, External Ventricular Drainage Associated Infection
- Being tested
- Sampling of blood and cerebrospinal fluid
- Medical subject headings
- Brain Injuries, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling of blood and cerebrospinal fluidOther
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the external ventricular drain duration (1-60 days)
Secondary outcomes (4)
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.
Measured: Throughout the external ventricular drain duration (1-60 days)
Functional outcome at six months
Functional outcome evaluated six months after the initial brain injury using:
- modified Rankin Scale (mRS) as favourable (0-2) or unfavourable (3-6)
Measured: 6 months after the initial brain injury
Functional outcome at six months
Functional outcome evaluated six months after the initial brain injury using:
- Glascow Outcome Score-Extended (GOS-E) as favorable (5-8) or unfavorable (0-4)
Measured: 6 months after the initial brain injury
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.
Measured: Throughout the external ventricular drain duration (1-60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start15 Jan 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 148 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pernille Rosenfeldt, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380477
- Sponsor's protocol ID
- H-24051777
- Other IDs
- p-2024-17691
- Acronym
- LACTIC
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will only be shared with a data sharing agreement
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSF Lactate and Ventriculostomy Associated Infections in Patients With Acute Brain Injury - a Prospective, Observational Cohort Study.
- ClinicalTrials.gov ID
- NCT07380477
- Acronym / sponsor ID
- LACTIC / H-24051777
- Conditions
- Acute Brain Injury, Hydrocephalus, External Ventricular Drain, External Ventricular Drainage Associated Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study involving patients with acute brain injury undergoing treatment with an external ventricular drain consists of three subprojects, aiming to:
- investigate various biomarkers, with a primary focus on the development of cerebrospinal fluid lactate in relation to ventriculostomy-associated infection;
- compare proximal and distal sample results obtained from an external ventricular drain;
- describe the natural progression of various biomarkers in blood and cerebrospinal fluid following acute brain injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute brain injury, that are treated with an external ventricular drain
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sampling of blood and cerebrospinal fluidAs 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) | Other | – |
Primary outcome
Concentration of cerebrospinal fluid lactate
Time frame: 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.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Undecided. IPD will only be shared with a data sharing agreement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Brain Injury and Hydrocephalus, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pernille Nielsen, Medical doctor (+45 22220775, pernille.nielsen.05@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of cerebrospinal fluid lactate (time frame: Throughout the external ventricular drain duration (1-60 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.