Actively Recruiting
Led by University Hospital, Basel, Switzerland · Updated on 2026-01-28
500
Participants Needed
4
Research Sites
52 weeks
Total Duration
Researchers are investigating the relationship between personalized cardiac anesthesia, cerebral blood flow regulation, and neurological outcomes in patients undergoing cardiac surgery. This international, multicenter prospective cohort study focuses on whether variations in mean arterial pressure (MAP) beyond an individual's cerebral autoregulation limits, measured using near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD), are linked to adverse neurological events such as postoperative delirium, stroke, and cognitive decline. The study also explores connections between neurological outcomes, brain injury biomarkers, and genetic factors to better understand and improve patient safety and quality of life. During the study, patients undergoing elective primary or reoperative cardiac surgeries involving coronary artery bypass graft, valvular, or ascending aorta procedures with cardiopulmonary bypass will be monitored. Preoperative assessments include cognitive and physical tests like the Montreal Cognitive Assessment (MoCA), Geriatric Depression Scale, and hand grip strength. Intraoperative data collection involves real-time monitoring of NIRS, TCD, and invasive arterial blood pressure. Postoperatively, NIRS monitoring continues in the ICU until extubation or 24 hours, and patients are assessed for delirium, stroke, and cognitive changes. Blood samples for brain injury biomarkers and genetic studies are collected at several time points before and after surgery. Participants will be evaluated daily for postoperative delirium using 3D-CAM and CAM-ICU from surgery day through up to seven days or discharge. Stroke severity and cognitive function are also regularly assessed, with follow-ups extending up to 12 months. Additional measures include renal function, intensive care unit stay, hospital length of stay, and mortality within 30 days. This comprehensive monitoring aims to identify whether cerebral hemodynamic insults correlate with neurological complications, supporting personalized patient care and future neuroprotective strategies.
CONDITIONS
Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Preoperative period
Participants undergo preoperative assessments including cognitive, mental, and physical status evaluations and collection of blood samples for biomarker and genetic studies.
1 baseline visit (in-person)
Duration - Surgery day and up to 24 hours post-surgery
Participants undergo cardiac surgery with real-time intraoperative monitoring of cerebral autoregulation and blood pressure. Postoperatively, monitoring continues in the ICU until extubation, 24 hours, or emergency re-operation.
Continuous monitoring during surgery and ICU stay (approximately 1 day)
Duration - Up to 12 weeks post-surgery
Participants are assessed daily for neurological outcomes including delirium, stroke, and cognitive decline. Blood samples for brain injury biomarkers are collected at multiple time points up to 12 weeks after surgery.
Daily visits for up to 7 days or until discharge; additional visits at postoperative days 1, 2, 6, and between 6 to 12 weeks
Total: 4 locations
1
Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
2
Inselspital, Bern University Hospital
Bern, Switzerland, 3010
Actively Recruiting
3
Cambridge University Hospitals and Brain Physics Lab
Cambridge, United Kingdom, CB2 0QQ
Active, Not Recruiting
4
Royal Papworth Hospital, Department of Anaesthesia and Intensive Care
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
N
Nuno V. Gomes, MD
L
Luzius A. Steiner, MD, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Nuno V Gomes, Harry Edgar-Whelan, Erta Beqiri...
https://pubmed.ncbi.nlm.nih.gov/41857828