RecruitingNCT05595954

Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery

Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery (PRECISION)

Sponsor

University Hospital, Basel, Switzerland

Enrollment

500 participants

Start Date

Jan 23, 2023

Study Type

OBSERVATIONAL

Conditions

Postoperative Delirium Postoperative Cognitive Dysfunction Postoperative Stroke

Summary

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.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Collection of blood sample for genetic study, Collection of serum biomarker panel, and others for people with postoperative cognitive dysfunction, postoperative delirium, and other related conditions. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 65 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPreoperative data collection

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. 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.

DIAGNOSTIC_TESTIntraoperative NIRS

Intraoperatively, NIRS data will be collected and recorded in real-time.

DIAGNOSTIC_TESTIntraoperative TCD

Intraoperatively, TCD data will be collected and recorded in real-time.

DIAGNOSTIC_TESTIntraoperative invasive MAP

Intraoperatively, invasive arterial blood pressure data will be collected and recorded in real-time.

DIAGNOSTIC_TESTPostoperative NIRS

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.

OTHERPostoperative data collection

Postoperatively 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.

DIAGNOSTIC_TESTCollection of serum biomarker panel

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). 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.

DIAGNOSTIC_TESTCollection of blood sample for genetic study

A blood sample for the genetic study will be obtained preoperatively.