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

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Description

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.

Study Overview

Start Date
January 23, 2023
Completion Date
January 1, 2026
Enrollment
500
Date Posted
October 27, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel
Basel 4031, Switzerland

Royal Papworth Hospital, Department of Anaesthesia and Intensive Care
Cambridge CB2 0QQ, United Kingdom

Eligibility

Study Population
The target population consists of in-hospital patients undergoing cardiac surgery in three centres of three countries in Europe. 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.
Minimum Age (years)
65
Eligibility Criteria
Inclusion Criteria:

Elective primary or reoperative coronary artery bypass graft and/or valvular and/or ascending aorta surgery requiring cardiopulmonary bypass.

Exclusion Criteria:

Surgery requiring moderate or deep hypothermic circulatory arrest;
Heart and/or lung transplantation;
Urgent (< 24 hours) and emergency surgery;
Inability to follow procedures or insufficient knowledge in English, German or French;
Inability to give consent.

Participants from the University Hospital Basel who undergo cardiac surgery under minimal extracorporeal circulation will also be excluded.

Study Contact Info

Study Contact Name
Nuno V. Gomes, MD; Luzius A. Steiner, MD, PhD

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
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.
NCTid (if applicable)
NCT05595954