Acute Brain InjuryNCT06302244
Multimodal Neuromonitoring in Acute Brain Injury
An observational study of Acute Brain Injury, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Brain Injury
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Mar 2017to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Age below 18 years
- Acute brain injury due to causes other than the above mentioned
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodal Neuromonitoring in Patients With Severe 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:
Read the 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:
- 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.
- Conditions
- Acute Brain Injury
- Keywords
- Brain injury, Intensive care, Neurointensive care, Anaesthesiology, Multimodal neuromonitoring
- Medical subject headings
- Brain Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between systemic glucose and microdialysis glucose
Median goodness of fit (Pearsons R2)
Measured: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)
Median goodness of fit (Pearsons R2) of the relationship between PaO2 (kPa) and PbtO2 (mmHg).
Median goodness of fit (Pearsons R2)
Measured: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)
Correlation between systemic lactate and microdialysis lactate when corrected for PbtO2 and cerebral perfusion pressure.
Median goodness of fit (Pearsons R2)
Measured: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)
The predictive value of glutamate measured by intracerebral microdialysis for episodes of neuroworsening
Area under the curve
Measured: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)
The predictive value of glutamate measured by intracerebral microdialysis for 6-month functional outcome
Modified Rankin Scale
Measured: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)
Secondary outcomes (5)
Length of hospital stay
Time in days
Measured: From admission until discharge (1-300 days)
Mixed effects linear regression of the relationship betwen PaO2 (kPa) and PbtO2 (mmHg).
mmHg/kPa
Measured: Six months after admission to the neuro-ICU
Functional outcome at six months
Modified Rankin Scale
Measured: Six months after admission to the neuro-ICU
Mortality at six months
Percent
Measured: Six months after admission to the neuro-ICU
Length of stay in the ICU
Time in days
Measured: From admission until discharge from the ICU (1-300 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start27 Mar 2017
- Primary completion31 Dec 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Sophie Worm Fenger, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kirsten W Møller, Study chair, Rigshospitalet, Afdeling for bedøvelse og intensiv behandling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302244
- Sponsor's protocol ID
- R-21075263
- Status last verified
- Jul 2025
- First submitted
- 4 Mar 2024
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andreasen TH, Olsen MH, Vassilieva A, Fenger AW, Lund A, Jensen HR, Forsse A, Moller K. Intracerebral Glutamate and Glycerol in Severe Acute Brain Injury: Retrospective Study of Association With Neuroworsening and Outcome. Acta Anaesthesiol Scand. 2026 Oct;70(9):e70333. doi: 10.1111/aas.70333.
PubMed 42722371Fenger AW, Lund A, Vassilieva A, Andreasen TH, Ebdrup SR, Bodilsen TS, Jensen HR, Olsen MH, Moller K. Relationship Between Systemic and Cerebral Microdialysate Glucose in Patients With Severe Acute Brain Injury-A Retrospective Study. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70078. doi: 10.1111/aas.70078.
PubMed 40528433
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Neuromonitoring in Patients With Severe Acute Brain Injury
- ClinicalTrials.gov ID
- NCT06302244
- Acronym / sponsor ID
- R-21075263
- Conditions
- Acute Brain Injury
- Keywords
- Brain injury, Intensive care, Neurointensive care, Anaesthesiology, Multimodal neuromonitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Age below 18 years
- Acute brain injury due to causes other than the above mentioned
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
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)
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
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
5 secondary outcomes
Length of hospital stay
Time frame: From admission until discharge (1-300 days)
Mixed effects linear regression of the relationship betwen PaO2 (kPa) and PbtO2 (mmHg).
Time frame: Six months after admission to the neuro-ICU
Functional outcome at six months
Time frame: Six months after admission to the neuro-ICU
Mortality at six months
Time frame: Six months after admission to the neuro-ICU
Length of stay in the ICU
Time frame: From admission until discharge from the ICU (1-300 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Derived from this study: PubMed 42722371Andreasen TH, Olsen MH, Vassilieva A, Fenger AW, Lund A, Jensen HR, Forsse A, Moller K. Intracerebral Glutamate and Glycerol in Severe Acute Brain Injury: Retrospective Study of Association With Neuroworsening and Outcome. Acta Anaesthesiol Scand. 2026 Oct;70(9):e70333. doi: 10.1111/aas.70333.
- Derived from this study: PubMed 40528433Fenger AW, Lund A, Vassilieva A, Andreasen TH, Ebdrup SR, Bodilsen TS, Jensen HR, Olsen MH, Moller K. Relationship Between Systemic and Cerebral Microdialysate Glucose in Patients With Severe Acute Brain Injury-A Retrospective Study. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70078. doi: 10.1111/aas.70078.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten W Møller study chair
Rigshospitalet, Afdeling for bedøvelse og intensiv behandling
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Brain Injury, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between systemic glucose and microdialysis glucose (time frame: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06302244, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.