Multimodal Neuromonitoring in Acute Brain Injury

Status Active, not recruiting

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:

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06302244
Study type	Observational
Source	Rigshospitalet, Denmark
Contact
Status	Active, not recruiting
Phase
Start date	March 27, 2017
Completion date	November 1, 2024

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.