Clinical trial NCT06302244: Multimodal Neuromonitoring in Acute Brain Injury
Official title: Multimodal Neuromonitoring in Patients With Severe Acute Brain Injury
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Brain Injury
Keywords: Brain injury
Intensive care
Neurointensive care
Anaesthesiology
Multimodal neuromonitoring
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe acute brain injury and diagnosis of traumatic brain injury or subarachnoid haemorrhage admitted to the neurointensive care unit at Copenhagen University Hospital Rigshospitalet

Brief summary: Acute brain injury due to aneurysmal subarachnoid haemorrhage (SAH) or traumatic brain injury (TBI) is a condition with a high mortality, and surviving patients often have permanent disabilities. Multimodal neuromonitoring of intracranial pressure, brain tissue oxygen tension (PbtO2), and brain energy metabolism (measured with microdialysis (MD)) may help individualise the treatment of this patient group to protect the brain and potentially improve outcomes. However, there is still a significant lack of knowledge regarding the advantages and disadvantages of this type of monitoring.

The present study consists of four substudies with the overall aim of examining which factors are most influential for regulating commonly measured intracerebral parameters such as oxygenation, glucose, and lactate. Additionally, the influence of these of parameters on functional outcome and mortality will be explored.

The individual studies are detailed below:

Detailed description: Substudy 1:

This study investigates the relationship between glucose in blood and microdialysate (MD-glucose) in patients with severe traumatic brain injury (TBI) or aneurysmal subarachnoid haemorrhage (SAH).

Substudy 2:

The aim of this substudy is to examine the contribution of arterial oxygen tension (PaO2) to PbtO2 in patients with acute brain injury. We hypothesize that there is an association between the two parameters, that this relationship is altered in patients with concurrent intracranial hypoertension, and that a higher burden of cerebral hypoxia is associated with poor functional outcome and mortality.

Substudy 3:

The study aims to estimate the contribution of systemic lactate to microdialysate lactate, hypothesizing that:

1. PbtO2 and cerebral perfusion pressure are independent predictors of microdialysate lactate in patients with cerebral hypoxia (PbtO2\<20).
2. Systemic lactate is an independent predictor of microdialysis lactate in patients without cerebral hypoxia.

Substudy 4:

The study aims to establish whether there is a predictive threshold value of MD-glutamate for unfavourable functional outcome 6 months after ictus of brain injury. Additionally, we aim to explore whether there is a pattern of MD-glutamate that can predict episodes of neuroworsening.

Eligibility criteria: Inclusion Criteria:

* Adult patients admitted to the Neurointensive care unit at Rigshospitalet, Copenhagen
* Diagnosis of traumatic brain injury or subarachnoid haemorrhage
* Multimodal neuromonitoring consisting intracranial pressure, brain tissue oxygen tension, and/or cerebral microdialysis

Exclusion Criteria:

* Age below 18 years
* Acute brain injury due to causes other than the above mentioned

Primary outcomes:
measure: Correlation between systemic glucose and microdialysis glucose
timeFrame: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)
measure: Median goodness of fit (Pearsons R2) of the relationship between PaO2 (kPa) and PbtO2 (mmHg).
timeFrame: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)
measure: Correlation between systemic lactate and microdialysis lactate when corrected for PbtO2 and cerebral perfusion pressure.
timeFrame: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)
measure: The predictive value of glutamate measured by intracerebral microdialysis for episodes of neuroworsening
timeFrame: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)
measure: The predictive value of glutamate measured by intracerebral microdialysis for 6-month functional outcome
timeFrame: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)
Secondary outcomes:
measure: Length of hospital stay
timeFrame: From admission until discharge (1-300 days)
measure: Mixed effects linear regression of the relationship betwen PaO2 (kPa) and PbtO2 (mmHg).
timeFrame: Six months after admission to the neuro-ICU
measure: Functional outcome at six months
timeFrame: Six months after admission to the neuro-ICU
measure: Mortality at six months
timeFrame: Six months after admission to the neuro-ICU
measure: Length of stay in the ICU
timeFrame: From admission until discharge from the ICU (1-300 days)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Afdeling for bedøvelse og intensiv behandling
name: Kirsten W Møller
role: STUDY_CHAIR
References: