Multimodal Neuromonitoring in Acute Brain Injury

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:

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Brain Injury

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Time in days	From admission until discharge (1-300 days)
Mixed effects linear regression of the relationship betwen PaO2 (kPa) and PbtO2 (mmHg).	mmHg/kPa	Six months after admission to the neuro-ICU
Functional outcome at six months	Modified Rankin Scale	Six months after admission to the neuro-ICU
Mortality at six months	Percent	Six months after admission to the neuro-ICU
Length of stay in the ICU	Time in days	From admission until discharge from the ICU (1-300 days)

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Study Chair: Kirsten W Møller, Rigshospitalet, Afdeling for bedøvelse og intensiv behandling

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Actual): June 1, 2023
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Intensive care; Brain injury; Anaesthesiology; Neurointensive care; Multimodal neuromonitoring
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: R-21075263

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No