Multimodal Neuromonitoring in Acute Brain Injury

NCT06302244 | Completed

• 1 other identifier: R-21075263
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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:

Conditions

Acute Brain Injury

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Correlation between systemic glucose and microdialysis glucose

  Median goodness of fit (Pearsons R2)

  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)

  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)

  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

  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

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

Secondary Outcomes (5)

• Length of hospital stay

  From admission until discharge (1-300 days)

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

  Six months after admission to the neuro-ICU

• Functional outcome at six months

  Six months after admission to the neuro-ICU

• Mortality at six months

  Six months after admission to the neuro-ICU

• Length of stay in the ICU

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 40528433 DERIVED

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kirsten W Møller

  Rigshospitalet, Afdeling for bedøvelse og intensiv behandling

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD fellow

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: March 27, 2017
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)