Clinical Trials Directory

Trials / Completed

CompletedNCT07285733

Multimodal Neuromonitoring at the ICU

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
University Hospital, Antwerp · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

Neurocritical care has become a distinct discipline within the field of intensive care medicine with a major focus on the treatment of patients with acute damage to the most complex organ of the human body, the brain. The main indications for acute neurocritical care concern aneurysmal Subarachnoid Hemorrhage (SAH) and severe Traumatic Brain Injury (TBI). These disease entities form a major health and socioeconomic problem as they afflict young patients and the rate of death and disability is high. The pathology and treatment of these patients is heterogeneous and complex. Despite advances in basic neuroscience which have increased our understanding of processes in the injured brain, approaches to management are largely unfocused and adhere to the concept of a 'one pill for everybody' approach. Novel monitoring technology and new neuroimaging techniques now offer opportunities for advancing the care for these patients to a more individualized targeted management. In the period of 2010-2014, a prospective trial was conducted in the Antwerp University Hospital, including 50 patients with either SAH or TBI, who underwent extensive monitoring, known as "Individualized targeted management in neurocritical care". In NEMO-RETRO, the investigators want to answer proposed and new research questions in retrospective analyses, using current insights and methodologies. Objectives: 1. Cerebral blood flow monitoring 1. Investigate the effect of changes in therapy (nature/intensity) on Cerebral Blood Flow (CBF) measured by thermal diffusion flowmetry and Transcranial Doppler (TCD) 2. Determine the added value of continuous CBF monitoring for the early detection of vasospasm and ischaemia 2. Brain tissue oxygen tension 1. Investigate the effect of changes in therapy (nature/intensity) on cerebral oxygenation as measured by Brain Tissue Oxygen Tension (PTiO2) 2. Investigate the relation between PTiO2 and hemodynamic parameters such as CBF, CPP, and ICP 3. Systemic effects of brain specific therapy 1. Investigate the effects of brain-targeted therapy on cardiac output and lung function 2. Determine the relation of CBF to cardiac output, in particular following triple H therapy 4. Neuroimaging 1. Accurately document structural brain damage following TBI and SAH 2. Document vasospasm and quantify flow and perfusion 3. Quantify the degree of secondary ischaemic damage to the brain 4. Differentiate swelling from edema 5. Train and validate models to interpret neuroimaging 5. Outcome 1. Assess global functional outcome at 6 months post-injury 2. Assess health-related quality of life at 6 months after injury 6. Integrated approach analysis 1. Describe the effects of brain-targeted therapy on cerebral and systemic parameters 2. Define the added value of extended multimodality monitoring and advanced neuroimaging to detect vasospasm and secondary ischaemic damage, defined by markers of neuronal injury and cell death 3. Develop recommendations for individualized targeted management

Conditions

Interventions

TypeNameDescription
DEVICEMultimodal neuromonitoringImaging: CT, MRI, XA Neuromonitoring: Brain Tissue Monitoring Probe, Hemedex, External ventricular drain, Cortical microdialysis catheter Other monitoring: Arterial catheter, Jugular bulb catheter, routine vital parameters

Timeline

Start date
2010-02-01
Primary completion
2014-04-01
Completion
2014-04-01
First posted
2025-12-16
Last updated
2025-12-16

Source: ClinicalTrials.gov record NCT07285733. Inclusion in this directory is not an endorsement.