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NCT Number: NCT07380477

VentricuLostomy AssoCiaTed InfeCtions (LACTIC): Focus on CSF Lactate and Sampling Site

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.

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Key information

Conditions

Acute Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma External Ventricular Drain External Ventricular Drainage Associated Infection Hydrocephalus Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sampling of blood and cerebrospinal fluid

Other

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. CSF lactate concentration change in patients developing ventriculostomy associated infection

    Time frame: 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.

  2. Functional outcome at six months

    Time frame: 6 months after the initial brain injury

    Functional outcome evaluated six months after the initial brain injury using:

    • modified Rankin Scale (mRS) as favourable (0-2) or unfavourable (3-6)

  3. Functional outcome at six months

    Time frame: 6 months after the initial brain injury

    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)

  4. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pernille Nielsen, Medical doctor

CONTACT

[email protected]

+45 22220775

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

CSF Lactate and Ventriculostomy Associated Infections in Patients With Acute Brain Injury - a Prospective, Observational Cohort Study.

Acronym: LACTIC

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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