Clinical trial NCT05595954: Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery
Official title: Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery (PRECISION)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Delirium
Postoperative Stroke
Postoperative Cognitive Dysfunction
Keywords: cerebral autoregulation
hypotension
neurological outcomes
adverse neurological events
postoperative delirium
postoperative stroke
postoperative cognitive decline
personalised cardiac anaesthesia
cardiac surgery
near-infrared spectroscopy
transcranial Doppler
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

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.

Primary outcomes:
measure: Change in 3D-CAM to assess postoperative delirium (POD)
timeFrame: Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier)
measure: Change in Confusion Assessment Method for the ICU (CAM-ICU) to assess postoperative delirium (POD)
timeFrame: Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier)
Secondary outcomes:
measure: Change in modified National Institutes of Health Stroke Scale (mNIHSS)
timeFrame: Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier)
measure: Change in Montreal Cognitive Assessment (MoCA)
timeFrame: Between 6 weeks and 12 weeks, and up to 12 months after surgery
measure: Postoperative increase in serum creatinine
timeFrame: Within 48 hours after surgery
measure: De novo renal replacement therapy
timeFrame: Within postoperative day 7 (or up to discharge)
measure: Major morbidity
timeFrame: Within postoperative day 7 (or up to discharge)
measure: Intensive care unit (ICU) stay (in hours)
timeFrame: From day of surgery until discharge from ICU (approx. 1 day)
measure: Length of hospital stay (in days)
timeFrame: From day of surgery until discharge from hospital (approx. 7 days)
measure: Perioperative mortality
timeFrame: Within within 30 days after surgery
measure: Change in brain injury biomarker panel
timeFrame: At preoperative screening; at day of surgery; at postoperative day 1, 2 and 7; between 6 weeks and 12 weeks after surgery
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik, Institut für Kardioanästhesiologie
city: Basel
country: Switzerland
facility: Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel
city: Bern
country: Switzerland
facility: Inselspital, Bern University Hospital
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals, Division of Anaesthesia and Brain Physics Lab
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital, Department of Anaesthesia and Intensive Care
Study officials:
affiliation: Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel
name: Nuno V. Gomes, MD
role: PRINCIPAL_INVESTIGATOR
References: