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

NCT07380477 | Recruiting

• 2 other identifiers: H-24051777p-2024-17691
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study involving patients with acute brain injury undergoing treatment with an external ventricular drain consists of three subprojects, aiming to:

1. 1.investigate various biomarkers, with a primary focus on the development of cerebrospinal fluid lactate in relation to ventriculostomy-associated infection;
2. 2.compare proximal and distal sample results obtained from an external ventricular drain;
3. 3.describe the natural progression of various biomarkers in blood and cerebrospinal fluid following acute brain injury.

Conditions

Hydrocephalus; External Ventricular Drainage Associated Infection; Acute Brain Injury; External Ventricular Drain

Outcome Measures

Primary Outcomes (1)

• 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.

  Throughout the external ventricular drain duration (1-60 days)

Secondary Outcomes (4)

• CSF lactate concentration change in patients developing ventriculostomy associated infection

  Throughout the external ventricular drain duration (1-60 days)

• Functional outcome at six months

  6 months after the initial brain injury

• Functional outcome at six months

  6 months after the initial brain injury

• Comparison of concentration of cerebrospinal fluid markers drawn from the proximal and distal port of the EVD

  Throughout the external ventricular drain duration (1-60 days)

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with acute brain injury, that are treated with an external ventricular drain

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Pernille Nielsen, Medical doctor

CONTACT

+45 22220775; pernille.nielsen.05@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD-student

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: February 2, 2026
• Study Start: January 15, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): October 1, 2029
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

DK (1)