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

RecruitingOBSERVATIONAL
Enrollment

500

Participants

Timeline

Start Date

January 23, 2023

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Postoperative DeliriumPostoperative StrokePostoperative Cognitive Dysfunction
Interventions
OTHER

Preoperative 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_TEST

Intraoperative NIRS

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

DIAGNOSTIC_TEST

Intraoperative TCD

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

DIAGNOSTIC_TEST

Intraoperative invasive MAP

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

DIAGNOSTIC_TEST

Postoperative 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.

OTHER

Postoperative 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_TEST

Collection of serum biomarker panel

The serum biomarker panel will consist of four markers of neurological injury glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL), t-tau and ubiquitin-C-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_TEST

Collection of blood sample for genetic study

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

Trial Locations (5)

3010

RECRUITING

Inselspital, Bern University Hospital, Bern

4031

RECRUITING

Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Basel

01307

NOT_YET_RECRUITING

Herzzentrum Dresden GmbH Universitätsklinik, Institut für Kardioanästhesiologie, Dresden

CB2 0QQ

ACTIVE_NOT_RECRUITING

Cambridge University Hospitals, Division of Anaesthesia and Brain Physics Lab, Cambridge

RECRUITING

Royal Papworth Hospital, Department of Anaesthesia and Intensive Care, Cambridge

All Listed Sponsors
lead

University Hospital, Basel, Switzerland

OTHER