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NCT Number: NCT06302244

Multimodal Neuromonitoring in Acute Brain Injury

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:

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Key information

Conditions

Acute Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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:

  • PbtO2 and cerebral perfusion pressure are independent predictors of microdialysate lactate in patients with cerebral hypoxia (PbtO2<20).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation between systemic glucose and microdialysis glucose

    Time frame: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)

    Median goodness of fit (Pearsons R2)

  2. Median goodness of fit (Pearsons R2) of the relationship between PaO2 (kPa) and PbtO2 (mmHg).

    Time frame: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)

    Median goodness of fit (Pearsons R2)

  3. Correlation between systemic lactate and microdialysis lactate when corrected for PbtO2 and cerebral perfusion pressure.

    Time frame: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)

    Median goodness of fit (Pearsons R2)

  4. The predictive value of glutamate measured by intracerebral microdialysis for episodes of neuroworsening

    Time frame: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)

    Area under the curve

  5. The predictive value of glutamate measured by intracerebral microdialysis for 6-month functional outcome

    Time frame: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)

    Modified Rankin Scale

Secondary outcomes

  1. Length of hospital stay

    Time frame: From admission until discharge (1-300 days)

    Time in days

  2. Mixed effects linear regression of the relationship betwen PaO2 (kPa) and PbtO2 (mmHg).

    Time frame: Six months after admission to the neuro-ICU

    mmHg/kPa

  3. Functional outcome at six months

    Time frame: Six months after admission to the neuro-ICU

    Modified Rankin Scale

  4. Mortality at six months

    Time frame: Six months after admission to the neuro-ICU

    Percent

  5. Length of stay in the ICU

    Time frame: From admission until discharge from the ICU (1-300 days)

    Time in days

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Multimodal Neuromonitoring in Patients With Severe Acute Brain Injury

Important dates

Study start
2017
Primary completion
2024
Study completion
2025
First posted
Mar 8, 2024
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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