At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Preoperative data collection (other), Intraoperative NIRS (diagnostic test), Intraoperative TCD (diagnostic test), Intraoperative invasive MAP (diagnostic test)
- How long the study runs
- Study runs about 53 months (dates as stated)
- About the drug or intervention
- Preoperative data collection — other: Preoperatively, patients will be assessed with Montreal Cognitive Assessment (MoCA), Geriatric Depression Scale (GDS), Clinical Frailty Scale, 3-minute Diagnostic interview for Confusion Assessment Method-defined delirium (3D-CAM, incl. · Intraoperative NIRS — diagnostic test: Intraoperatively, NIRS data will be collected and recorded in real-time. · Intraoperative TCD — diagnostic test: Intraoperatively, TCD data will be collected and recorded in real-time. · Intraoperative invasive MAP — diagnostic test: Intraoperatively, invasive arterial blood pressure data will be collected and recorded in real-time. · Postoperative NIRS — diagnostic test: Postoperatively, NIRS monitoring will be continued in the ICU after the surgery until (i) endotracheal extubation, or (ii) for the first 24 hours or (iii) until emergency re-operation, whichever occurs first. · Postoperative data collection — other: Postoperatively patients will be evaluated for POD with 3D-CAM or CAM-ICU and for clinical stroke with mNIHSS. · Collection of serum biomarker panel — diagnostic test: The serum biomarker panel will consist, at least, of four markers of neurological injury glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL), total tau and ubiquitin-carboxy-terminal hydrolase-L1 (UCH-L1). · Collection of blood sample for genetic study — diagnostic test: A blood sample for the genetic study will be obtained preoperatively.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at whether tailoring anaesthesia (medicine that keeps you asleep during surgery) to each patient, while monitoring how the brain controls its own blood flow, can help protect the brain during heart surgery. The researchers are studying three problems that can happen after an operation: delirium (sudden confusion), stroke, and trouble with memory or thinking.
Who can take part
- Adults having planned heart surgery on the heart arteries, valves, or the main artery leaving the heart (the ascending aorta), where a heart-lung bypass machine is used
- This includes both first-time and repeat operations
Who may not be able to
- Surgery where the body is cooled to low or very low temperatures and blood flow is stopped for a period
- Heart or lung transplant surgery
- Surgery that must happen urgently (within 24 hours) or as an emergency
- People who cannot follow the study procedures, or who do not understand English, German or French well enough
- People who cannot give their own consent to take part
- Surgery done using a type of bypass called 'minimal extracorporeal circulation'
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 65 Years and over
- Who
- All
- Number of participants
- 500
- Started
- 2023-01-23
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for postoperative delirium
- • Clinical study - 500 participants
- • This international, multicentre prospective cohort study will assess whether perioperative duration and magnitude of mean arterial pressure (MAP) outside of an individual's cerebral autoregulation (CA) limits using near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD) are associated with adverse neurological events
Who can take part?
- • Ages 65 Years and over
- • Diagnosed with postoperative delirium
Where?
- • Cambridge - Cambridge University Hospitals and Brain Physics Lab
- • Cambridge - Royal Papworth Hospital, Department of Anaesthesia and Intensive Care
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This international, multicentre prospective cohort study will assess whether perioperative duration and magnitude of mean arterial pressure (MAP) outside of an individual's cerebral autoregulation (CA) limits using near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD) are associated with adverse neurological events. It is to investigate whether patients with a higher burden of cerebral haemodynamic insults have an increased incidence or poorer neurological outcomes. Associations between neurologic outcomes, neurobiomarkers and genetic tests will be explored.
More detail
Adverse neurological events include perioperative neurocognitive disorders and stroke and remain one of the major risks after cardiac surgery. A lack of a comprehensive knowledge of their causes and neuroprotective strategies has hindered the development of strategies to effectively reduce these complications. Against this background, this research project will take three approaches. First, non-invasive, personalised cerebral autoregulation-oriented blood pressure monitoring aims to reduce complications by uncovering blood pressure targets tailored to individual characteristics. In parallel, establishing biological associations between adverse neurological outcomes, brain injury biomarkers and genetic studies are complementary strategies that make a move to a proactive patient-tailored paradigm, ultimately understanding the mechanisms and improving patient outcomes, patient safety and quality of life. Therefore, this international, multicentre prospective cohort study will assess whether perioperative duration and magnitude of MAP outside of an individual's CA limits using NIRS and TCD are associated with adverse neurological events. It is to investigate whether patients with a higher burden of cerebral haemodynamic insults, defined by the duration and magnitude spent outside of an individual's CA limits based on NIRS and/or TCD, have an increased incidence of postoperative delirium (POD), stroke or cognitive decline. Biological associations between adverse neurological outcomes, the role of brain injury serum biomarkers will be explored. Genetic studies will be conducted on participants who give written informed consent for these further investigations.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 65 Years and over
- Who can join: All genders
What the study is looking for
- ✓Elective primary or reoperative coronary artery bypass graft and/or valvular and/or ascending aorta surgery...
Who cannot take part
- ✗Surgery requiring moderate (28-31.9ºC) or deep (\<28ºC) hypothermic circulatory arrest;
- ✗Heart and/or lung transplantation;
- ✗Urgent (within 24 hours) and emergency surgery;
- ✗Inability to follow procedures or insufficient knowledge in English, German or French;
- ✗Inability to give consent.
See the full criteria
Where Is This Study? (2 UK sites)
Cambridge University Hospitals and Brain Physics Lab
Cambridge CB2 0QQ, United Kingdom
Royal Papworth Hospital, Department of Anaesthesia and Intensive Care
Cambridge CB2 0QQ, United Kingdom
How to Get in Touch
Nuno V. Gomes, MD
Sponsor contactCONTACT
Luzius A. Steiner, MD, PhD
Sponsor contactCONTACT