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

NCT05595954 | Recruiting

• 1 other identifier: 2022-01457; am22Gomes
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier)

• 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.

  Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier)

Secondary Outcomes (9)

• Change in modified National Institutes of Health Stroke Scale (mNIHSS)

  Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier)

• Change in Montreal Cognitive Assessment (MoCA)

  Between 6 weeks and 12 weeks, and up to 12 months after surgery

• Postoperative increase in serum creatinine

  Within 48 hours after surgery

• De novo renal replacement therapy

  Within postoperative day 7 (or up to discharge)

• Major morbidity

  Within postoperative day 7 (or up to discharge)

Interventions

Preoperative data collection OTHER

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.

Intraoperative NIRS DIAGNOSTIC_TEST

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

Intraoperative TCD DIAGNOSTIC_TEST

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

Intraoperative invasive MAP DIAGNOSTIC_TEST

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

Postoperative NIRS DIAGNOSTIC_TEST

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.

Postoperative data collection OTHER

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.

Collection of serum biomarker panel DIAGNOSTIC_TEST

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.

Collection of blood sample for genetic study DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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;
• Inability to give consent.
• Participants who undergo cardiac surgery under minimal extracorporeal circulation will also be excluded.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (4)

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

Basel, 4031, Switzerland

RECRUITING

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

Cambridge University Hospitals and Brain Physics Lab

Cambridge, CB2 0QQ, United Kingdom

ACTIVE NOT RECRUITING

Royal Papworth Hospital, Department of Anaesthesia and Intensive Care

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

Related Publications (1)

• Gomes NV, Edgar-Whelan H, Beqiri E, Young J, Schindler C, Gregor M, Erb JM, Siegemund M, Kuhle J, Maleska Maceski A, Needham E, Cichon S, Burger B, Monsch AU, Hasemann W, Wuest A, Fassl J, Kaiser HA, Hight D, Levis A, Gunsch D, Menon DK, Czosnyka M, Smielewski P, Klein AA, Dell-Kuster S, Steiner LA. PRECISION study: impact of personalised cardiac anaesthesia and cerebral autoregulation on neurological outcomes in patients undergoing cardiac surgery - protocol for an international, multicentre, prospective cohort study. BMJ Open. 2026 Mar 18;16(3):e115288. doi: 10.1136/bmjopen-2025-115288.

  PMID: 41857828 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The remaining biological materials (non-genetic and genetic) will be stored in biobanks in accordance with local technical and legal standards for 10 years after publication of this study for future research projects that have not yet been defined in more detail and for which a ethical approval will be attained.

MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications; Hypotension

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Cognition Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nuno V. Gomes, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuno V. Gomes, MD

CONTACT

+41 61 328 64 46; nuno.gomes@usb.ch

Luzius A. Steiner, MD, PhD

CONTACT

+ 41 61 328 64 74; luzius.steiner@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 27, 2022
• Study Start: January 23, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

CH (2); GB (2)