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Post-operative DeliriumNCT06236854

Neuroimaging Risk of Postoperative Delirium

An observational study of Post-operative Delirium, run by Technical University of Munich at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Postoperative delirium (POD) is a frequent disorder of consciousness, arousal and attention in elderly patients following surgery. The glymphatic system is a newly discovered waste cleaning system of the brain. Glymphatic transport of CSF has been shown to be impaired by perioperative factors. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Post-operative Delirium
What is being tested?
Delirium assessment (observational, not interventional)
How many people
150 participants
Where
1 siteGermany
Study dates
9 Oct 2023to Oct 2025
How long will I take part?
5 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Older adult

Study population: Older-aged elective surgical patients

Who may be able to join

  • >= 65 years of age
  • Fluent in German
  • Presence of at least one further risk factor for POD

Who cannot join

  • Individuals who do not meet all inclusion criteria
  • Scheduled for neurological surgery
  • Pre-existing neurological structural impairments or previous brain surgery
  • ASA status 4
  • Contraindication to MRI (e.g., pacemakers, artificial heart valves, cardioseal, aneurysm clips, implanted magnetic metal parts (screws, plates from surgery), cochlear implants, metal splitters/grenade splinters, acupuncture needle, insulin pump, piercings that cannot be removed, etc)
  • Scheduled for emergency procedures
  • Subjects with fear of confined spaces

Trial locations and contacts

1 site in 1 country.

Rachel Nuttall, PhD contact

0894140 ext. 8683

rachel.nuttall@tum.de

Svenja Letz, Dr med contact

0894140 ext. 4291

svenja.letz@mri.tum.de

Germany1 site, 1 recruiting
  • Klinikum rechts der Isar der Technischen Universität München

    München, Bavaria, 81675

    Rachel Nuttall, PhD, 0894140 ext. 8683, rachel.nuttall@tum.de

    Recruiting

Other trials in Germany

About this study

Official title: Investigating the Link Between Preoperative Glymphatic Transport and Postoperative Delirium

Postoperative delirium (POD) is a frequent disorder of consciousness, arousal and attention in elderly patients following surgery. The glymphatic system is a newly discovered waste cleaning system of the brain. Glymphatic transport of CSF has been shown to be impaired by perioperative factors. Reduced glymphatic transport has been related to a vicious cycle of neuroinflammatory marker build-up, leading to increased glymphatic transport impairment, leading eventually to neuronal damage and hence cognitive impairment. Therefore, glymphatic transport impairment has been suggested to be an important mechanism underlying POD. But not everyone who undergoes surgery presents POD, so what makes certain patients susceptible to POD? It has been suggested that glymphatic transport may already be impaired at preoperative baseline, which, with the added burden of perioperative strain on the system, 'tilts' the patient into POD. The primary aim of the current study is to measure glymphatic transport in patients preoperatively and assess whether patients who present POD ('POD patients') show impairments in preoperative glymphatic transport, relative to patients who do not present POD ('noPOD patients'). Two aspects of glymphatic transport will be assessed using two noninvasive MR techniques - fast-acquisition BOLD-fMRI and DTI-MR. POD will be assessed using the 3D-CAM questionnaire and patients will also be assessed preoperatively for symptoms of depression, state/trait anxiety and cognitive status using standardised self-report measures.

Read the detailed description

Delirium is a fluctuating disturbance of consciousness with accompanying impairments in attention, cognition, perception, emotional regulation, psychomotor abilities as well as sleep-wake cycle regulation. Delirium frequently occurs following surgery with general anaesthesia and presents a common postoperative complication in elderly patients (>=65 years). 'Postoperative delirium' (POD) refers to the occurrence of delirium from as early as the timepoint immediately following surgery, i.e., at emergence from general anaesthesia, and up to 30 days following surgery. The reported occurrence of POD is highly variable, ranging from 10% to 70%, depending on the age of patients, diagnostic criteria, and the type of surgery. Those especially vulnerable are the oldest patients with the most medically complex cases undergoing cardiac, vascular, or hip fracture surgery. POD is associated with functional decline; a linear association between mortality and number of delirious days has been reported. POD has also been shown to increase risk of dementia up to 10-fold alongside a 2-fold increase in risk of institutionalisation and death. POD increases the length of general hospital stay and is associated with more than doubling one-year medical costs. Hence, there is a drive to elucidate the mechanisms of POD and identify risk factors that can facilitate adequate patient care management to reduce POD occurrence, both from a health and a costs perspective.

Several risk factors for POD have been identified, which can be categorised into two groups based on when they occur relative to surgery. Preoperative 'baseline' risk factors for POD include older age, pre-existing cognitive impairment, sensory and functional impairment, use of psychotropic drugs, history of major depressive disorder (MDD), institutional residence and greater comorbidity, especially with regards to cardiovascular disease. Peri-/intraoperative 'precipitating' risk factors include perioperative pain, environmental unfamiliarity, type of surgery, disrupted sleep, anaesthetic dosage, use of a bladder catheter and the type of medications used. An individual's risk of POD has been modelled as a sum of these baseline and precipitating risk factors, where a heightened burden of baseline preoperative factors necessitates fewer peri/intraoperative precipitating factors to induce POD. This interaction between baseline and precipitating factors follows the hypothesis of neural functional reserve, which suggests that an individual's ability to tolerate situations that encompass stress to the brain or brain 'injury' is dependent upon their baseline functional reserve - representing a patient's 'resilience'. Baseline preoperative risk factors of POD can be seen as factors that reduce a patient's reserve or resilience, and peri-/intraoperative 'precipitating' risk factors can be seen as prime examples of situations encompassing stress on the brain. A low functional reserve has been shown to be an independent risk factor for POD. Therefore, investigations of the underlying baseline preoperative neurological impairments that have the effect of reducing a patient's resilience to peri-/intraoperative stressors - and increase their risk of POD - are highly warranted. The investigators will assess whether two potential baseline preoperative neural impairments contribute to a patient's risk of POD.

The glymphatic system is a recently discovered waste clearance system of the brain, utilising the perivascular channels to sweep cerebrospinal fluid (CSF) through and away from the brain's parenchyma, taking waste products and extracellular metabolites with it, essentially cleaning the brain. Aquaporin-4 water channels located at astrocytic end-feed form an essential component of this system, facilitating CSF movement from perivascular spaces into the interstitial space. There are a small number of non-invasive measures available to assess aspects of glymphatic system function in humans. The first measure was proposed by whereby fast fMRI acquisition (TR<400ms) - with the boundary edge of the volume (i.e., slice 0) placed at the level of the fourth ventricle - allows for the detection of fluid inflow arriving at the edge of the imaging volume with high signal intensity. The acquired CSF signal with slow oscillations at around 0.05Hz were found to be of significantly higher amplitude during sleep vs. wake, driven by slow neural oscillations in the delta range (~1-4Hz), and was anticorrelated with fluctuations in the global grey matter BOLD signal. A decrease in this anticorrelation was reported in patients with Parkinson's disease and was significantly related to lower cognitive performance on the Montreal Cognitive Assessment tool. A relationship between reduced global BOLD-CSF flow coupling and severity of small vessel disease has been reported, related to increased dilation of the perivascular space. Hence, the global BOLD-CSF coupling could provide an indication as to impaired glymphatic transport.

A second recent approach was developed using diffusion tensor imaging (DTI) of diffusion-weighted images to evaluate the motion of water molecules along deep medullary veins and their accompanying perivascular spaces running perpendicular to the ventricular walls on a transverse slice at the level of the lateral ventricle bodies. At this location, the distribution of different fibre types allows for the discernment of water diffusivity along the perivascular space independently from that within corticofugal corona radiata projection fibres (running in the craniocaudal direction, i.e., z-axis) and superior longitudinal fascicle association fibres (running in the anterior-posterior direction, i.e., y-axis). This approach, called the 'DTI-ALPS' method, i.e., 'diffusion tensor imaging along the perivascular space', can non-invasively measure glymphatic transport (i.e., CSF flow through the perivascular space) at this specific location, as the perivascular space runs perpendicular to both the projection and association fibres. Regions of interest are first manually labelled from a T1-weighted scan to measure diffusivities within these fibres along three directions (x, y, and z). Perivascular diffusion can be evaluated independently from diffusion along projection and association areas by identifying the ratio of the mean x-axis diffusivity in both areas to the mean diffusivity of these areas at the axes perpendicular to the x-axis and fibre tracts, i.e., the y-axis for projection fibres and z-axis for association fibres.

Perioperative factors such as the type of GA, in combination with various other perioperative factors, may alter postoperative brain function by affecting the glymphatic system. Dysfunction of this system that removes harmful metabolites from the brain can lead to neurological disorders and neuroinflammation. Reduced glymphatic system transport leads to an increased accumulation of amyloid-beta and tau, inducing neuroinflammation leading to a chain of processes that end in neuronal damage. Postoperative increases in amyloid-beta and tau have been reported and shown to be a risk factor for POD. As outlined above, different anaesthetics have differential effects on the glymphatic system, and anaesthetic type has been shown to be a risk factor for POD in patients. Volatile anaesthetics such as isoflurane or sevoflurane have a higher chance of causing POD, whereas intravenous anaesthetics such as dexmedetomidine and propofol seemingly rather have a protective effect against POD.

Elderly patients but not young people are highly susceptible to POD, triggering the question of why this group is selectively susceptible. As outlined previously, preoperative risk factors for POD include preclinical Alzheimer's disease, cerebral microemboli, vascular dementia, hyperglycaemia and other neurovascular diseases or neurodegeneration, all of which show glymphatic transport impairment. Ageing is associated with degenerative changes such as depolarised or downregulated aquaporin-4, sleep deprivation, and reduced cerebrovascular pulsatility, all of which have the potential to impair glymphatic system transport. In line with the functional reserve hypothesis, it has been suggested that susceptible patients at risk of POD have pre-existing glymphatic system impairment that progresses slowly without significant cognitive impairment, and that the perioperative risk factors exacerbate the pre-existing glymphatic damage beyond the compensatory limit, resulting in significant cognitive changes. This theory suggests that baseline preoperative measures of glymphatic system transport can be informative on the risk of POD. Our primary aim is to investigate whether baseline preoperative measures of glymphatic system transport can be useful in identifying patients at risk of POD, utilising the two non-invasive MR-based measures outlined previously.

The overall aim of the current study is to investigate potential underlying pathobiological mechanisms that contribute to POD, to further understand the mechanisms of this frequent disorder in the elderly and enhance perioperative care and patient management. Whether an impairment in glymphatic system transport at preoperative baseline can be informative on risk of POD will be assessed. All target values will be assessed at preoperative baseline. Assessment of whether a patient is classified as a 'POD patient' or a 'noPOD patient' is based on a diagnosis of delirium on any of the five days following surgery (including the day of surgery).

Being tested
Delirium assessment (observational, not interventional)
Medical subject headings
Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Delirium assessment (observational, not interventional)Other

    As an observational study, we will assess the presence of postoperative delirium in the enrolled patients, which will define their group membership.

Study groups in NCT06236854
Study groupRoleWhat they receive
POD-AbsentThe group of older-aged surgical patients who are not diagnosed with delirium as assessed for the following fives days post-surgery.
Receives: Other: Delirium assessment (observational, not interventional)
POD-PresentThe group of older-aged surgical patients who are diagnosed with delirium as assessed for the following fives days post-surgery.
Receives: Other: Delirium assessment (observational, not interventional)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Component of the brain waste clearance system as measured via magnetic resonance imaging

    Glymphatic system transport measured via diffusion tensor imaging/functional magnetic resonance imaging parameter of CSF flow coupling with global neurovascular activity at preoperative baseline is changed in POD-Present patients as compared with POD-Absent patients

    Measured: Morning prior to surgery during 30 minute MR protocol

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2024
  2. Study start9 Oct 2023
  3. Primary completionOct 2024 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
Target duration
5 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06236854
Sponsor's protocol ID
NeuRO-POD
Status last verified
Oct 2023
First submitted
10 Oct 2023
Last updated
1 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fultz NE, Bonmassar G, Setsompop K, Stickgold RA, Rosen BR, Polimeni JR, Lewis LD. Coupled electrophysiological, hemodynamic, and cerebrospinal fluid oscillations in human sleep. Science. 2019 Nov 1;366(6465):628-631. doi: 10.1126/science.aax5440.

    PubMed 31672896
  • Taoka T, Masutani Y, Kawai H, Nakane T, Matsuoka K, Yasuno F, Kishimoto T, Naganawa S. Evaluation of glymphatic system activity with the diffusion MR technique: diffusion tensor image analysis along the perivascular space (DTI-ALPS) in Alzheimer's disease cases. Jpn J Radiol. 2017 Apr;35(4):172-178. doi: 10.1007/s11604-017-0617-z. Epub 2017 Feb 14.

    PubMed 28197821
  • Ren X, Liu S, Lian C, Li H, Li K, Li L, Zhao G. Dysfunction of the Glymphatic System as a Potential Mechanism of Perioperative Neurocognitive Disorders. Front Aging Neurosci. 2021 Jun 7;13:659457. doi: 10.3389/fnagi.2021.659457. eCollection 2021.

    PubMed 34163349
  • Han F, Chen J, Belkin-Rosen A, Gu Y, Luo L, Buxton OM, Liu X; Alzheimer's Disease Neuroimaging Initiative. Reduced coupling between cerebrospinal fluid flow and global brain activity is linked to Alzheimer disease-related pathology. PLoS Biol. 2021 Jun 1;19(6):e3001233. doi: 10.1371/journal.pbio.3001233. eCollection 2021 Jun.

    PubMed 34061820
  • Han F, Brown GL, Zhu Y, Belkin-Rosen AE, Lewis MM, Du G, Gu Y, Eslinger PJ, Mailman RB, Huang X, Liu X. Decoupling of Global Brain Activity and Cerebrospinal Fluid Flow in Parkinson's Disease Cognitive Decline. Mov Disord. 2021 Sep;36(9):2066-2076. doi: 10.1002/mds.28643. Epub 2021 May 17.

    PubMed 33998068

Questions about this trial

What is this clinical trial studying?

An observational study of Post-operative Delirium, run by Technical University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rachel Nuttall, PhD (0894140 ext. 8683, rachel.nuttall@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Component of the brain waste clearance system as measured via magnetic resonance imaging (time frame: Morning prior to surgery during 30 minute MR protocol). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06236854, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.

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