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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Sampling of blood and cerebrospinal fluid

    Other intervention

    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)

Treatment groups

No treatment groups listed

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
Throughout the external ventricular drain duration (1-60 days)
2

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)

Time frame
6 months after the initial brain injury
3

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)

Time frame
6 months after the initial brain injury
4

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.

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

Other outcomes

Sponsors and contacts

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