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Multimodal Neuromonitoring in Acute Brain Injury

Multimodal Neuromonitoring in Patients With Severe Acute Brain Injury

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06302244
Enrollment
200
Registered
2024-03-08
Start date
2017-03-27
Completion date
2025-06-30
Last updated
2025-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Brain Injury

Keywords

Brain injury, Intensive care, Neurointensive care, Anaesthesiology, Multimodal neuromonitoring

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.

Interventions

None listed

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The predictive value of glutamate measured by intracerebral microdialysis for 6-month functional outcomeThroughout the duration of neuromonitoring in the neuro-ICU (1-30 days)Modified Rankin Scale
Correlation between systemic glucose and microdialysis glucoseThroughout the duration of neuromonitoring in the neuro-ICU (1-30 days)Median goodness of fit (Pearsons R2)
Median goodness of fit (Pearsons R2) of the relationship between PaO2 (kPa) and PbtO2 (mmHg).Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)Median goodness of fit (Pearsons R2)
Correlation between systemic lactate and microdialysis lactate when corrected for PbtO2 and cerebral perfusion pressure.Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)Median goodness of fit (Pearsons R2)
The predictive value of glutamate measured by intracerebral microdialysis for episodes of neuroworseningThroughout the duration of neuromonitoring in the neuro-ICU (1-30 days)Area under the curve

Secondary

MeasureTime frameDescription
Length of hospital stayFrom admission until discharge (1-300 days)Time in days
Mixed effects linear regression of the relationship betwen PaO2 (kPa) and PbtO2 (mmHg).Six months after admission to the neuro-ICUmmHg/kPa
Functional outcome at six monthsSix months after admission to the neuro-ICUModified Rankin Scale
Mortality at six monthsSix months after admission to the neuro-ICUPercent
Length of stay in the ICUFrom admission until discharge from the ICU (1-300 days)Time in days

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026