Multimodal Neuromonitoring in Acute Brain Injury

Acute Brain Injury Clinical Trial

Official title:

Multimodal Neuromonitoring in Patients With Severe Acute Brain Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06302244
• Other study ID #: R-21075263
• Status: Active, not recruiting
• Start date: March 27, 2017
• Est. completion date: November 1, 2024

Study information

• Verified date: March 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: November 1, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Brain Injury
• Brain Injuries
• Wounds and Injuries

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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