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

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:

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Brain Injury; Hydrocephalus; External Ventricular Drain; External Ventricular Drainage Associated Infection
• Intervention / Treatment: Other: Sampling of blood and cerebrospinal fluid

• Study Type: Observational
• Enrollment (Estimated): 148

Contacts and Locations

• Study Contact: Name: Pernille Nielsen, Medical doctor; Phone Number: +45 22220775; Email: pernille.nielsen.05@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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: 1) modified Rankin Scale (mRS) as favourable (0-2) or unfavourable (3-6)	6 months after the initial brain injury
Functional outcome at six months	Functional outcome evaluated six months after the initial brain injury using: 2) Glascow Outcome Score-Extended (GOS-E) as favorable (5-8) or unfavorable (0-4)	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.	Throughout the external ventricular drain duration (1-60 days)

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Hydrocephalus
• Other Study ID Numbers: H-24051777; p-2024-17691 (Other Identifier: Privacy, Capital Region of Denmark)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD will only be shared with a data sharing agreement

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No