Multimodal Neuromonitoring in Acute Brain Injury

NCT ID: NCT06302244

Last Updated: 2025-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-27

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Acute Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Anne-Sophie Worm Fenger

MD, PhD fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kirsten W Møller

Role: STUDY_CHAIR

Rigshospitalet, Afdeling for bedøvelse og intensiv behandling

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Fenger 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.

Reference Type DERIVED
PMID: 40528433 (View on PubMed)

Other Identifiers

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R-21075263

Identifier Type: -

Identifier Source: org_study_id

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