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.
Elective primary or reoperative coronary artery bypass graft and/or valvular and/or ascending aorta surgery requiring cardiopulmonary bypass.
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;
The target population consists of in-hospital patients undergoing cardiac surgery at three centres in two European countries. Patients will be screened for eligibility. Therefore, consecutive ongoing recruitment of patients fulfilling the in- and exclusion criteria will take place during daily clinical practice at the participating hospitals.
Cohort
Prospective
Preoperative data collection
Other interventionPreoperatively, 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. severity score), modified National Institutes of Health Stroke Scale (mNIHSS), and hand grip strength measurement (using a hand dynamometer) to establish a baseline measurement of the physical, cognitive and mental status.
Intraoperative NIRS
Diagnostic testIntraoperatively, NIRS data will be collected and recorded in real-time.
Intraoperative TCD
Diagnostic testIntraoperatively, TCD data will be collected and recorded in real-time.
Intraoperative invasive MAP
Diagnostic testIntraoperatively, invasive arterial blood pressure data will be collected and recorded in real-time.
Postoperative NIRS
Diagnostic testPostoperatively, 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 interventionPostoperatively patients will be evaluated for POD with 3D-CAM or CAM-ICU and for clinical stroke with mNIHSS. Postoperative neurocognitive disorders will be assessed using MoCA.
Collection of serum biomarker panel
Diagnostic testThe 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). Blood samples will be obtained preoperatively, after ICU admission, on postoperative day 1, 2, 6 (or hospital discharge, whichever occurs first) and between 6 and 12 weeks after surgery.
Collection of blood sample for genetic study
Diagnostic testA blood sample for the genetic study will be obtained preoperatively.
Change in 3D-CAM to assess postoperative delirium (POD)
Change in 3D-CAM to assess POD. The 3D-CAM rates four diagnostic features, including acute onset and fluctuating course, inattention, disorganized thinking, and altered level of consciousness. Delirium scored as 'present' (1) or 'absent' (0) based on question responses.
Change in Confusion Assessment Method for the ICU (CAM-ICU) to assess postoperative delirium (POD)
CAM-ICU is an adaptation of the CAM to be usable by clinicians to screen for delirium in the intensive care unit setting designed for intubated patients. The CAM-ICU utilizes the CAM diagnostic algorithm. There are four core features including acute onset or fluctuating course, inattention, disorganized thinking, and altered level of consciousness rated with 8 items. 3 of the 4 features must be present for CAM-ICU to be considered positive, according to the original CAM algorithm. Items are rated absent/present base on specific thresholds.
Change in modified National Institutes of Health Stroke Scale (mNIHSS)
Change in mNIHSS to assess postoperative clinical stroke
Change in Montreal Cognitive Assessment (MoCA)
Change in MoCA to assess postoperative neurocognitive disorder
Postoperative increase in serum creatinine
Postoperative increase in serum creatinine of ≥ 26.5 μmol/l (≥ 0.3 mg/dl) within 48 hours or ≥ 1.5 times of baseline to assess acute kidney injury
De novo renal replacement therapy
De novo renal replacement therapy
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