CompletedNot Applicable

Multimodal Neuromonitoring at the ICU

50 participantsStarted 2010-02

Plain-language 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

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

This study is based on the 50 patients recruited for the original study. For TBI: Inclusion Criteria: * male or female patients aged 18 to 70 years, inclusive * sustained head injury within the previous 24 hours * TBI diagnosed by history, clinical examination with a GCS of 12 or less * evidence of TBI confirmed by abnormalities on CT scan * clinical indication to monitor ICP * informed consent is obtained from the patient or from a legally acceptable representative Exclusion Criteria: * life expectancy of less than 24 hours as determined by the investigator * any spinal cord injury * coma suspected to be primarily due to causes other than head injury, such as drug or alcohol overdose * clinically significant or active gastro-intestinal, renal, hepatic, endocrine or CNS disease or chronic condition (e.g.psychiatric disorder) that can be ascertained at the time of admission and could affect functional outcome * respiratory/hemodynamic instability, refractory to treatment and precluding transport for neuroimaging studies * pregnancy * special exclusion criteria for MRI, such as non-removable metals, artificial joints, electronic devices (pacemaker, pumps etc.) * informed consent is obtained from a legally acceptable representative, prior to any study related activity For aneurysmal subarachnoid hemorrhage: Inclusion Criteria: * male or female patients aged 18 to 70 years, inclusive * ruptured aneurysm, demonstrated by CT angiography or DSA * onset of SAH clinical sympto…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with a favourable neurological outcome

Timeframe: From enrollment to the end of follow-up at 6 months

Trial details

NCT IDNCT07285733

SponsorUniversity Hospital, Antwerp

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-04

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