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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Диагностический тест Intraoperative NIRS
  Intraoperatively, NIRS data will be collected and recorded in real-time.
• Диагностический тест Intraoperative TCD
  Intraoperatively, TCD data will be collected and recorded in real-time.
• Диагностический тест Intraoperative invasive MAP
  Intraoperatively, invasive arterial blood pressure data will be collected and recorded in real-time.
• Диагностический тест 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.
• Другое 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.
• Диагностический тест Collection 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.
• Диагностический тест Collection of blood sample for genetic study
  A blood sample for the genetic study will be obtained preoperatively.

Первичные конечные точки

• Change in 3D-CAM to assess postoperative delirium (POD) [Срок оценки: 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) [Срок оценки: Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier)]

Вторичные конечные точки (9)

• Change in modified National Institutes of Health Stroke Scale (mNIHSS) [Срок оценки: Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier)]
• Change in Montreal Cognitive Assessment (MoCA) [Срок оценки: Between 6 weeks and 12 weeks, and up to 12 months after surgery]
• Postoperative increase in serum creatinine [Срок оценки: Within 48 hours after surgery]
• De novo renal replacement therapy [Срок оценки: Within postoperative day 7 (or up to discharge)]
• Major morbidity [Срок оценки: Within postoperative day 7 (or up to discharge)]
• Intensive care unit (ICU) stay (in hours) [Срок оценки: From day of surgery until discharge from ICU (approx. 1 day)]
• Length of hospital stay (in days) [Срок оценки: From day of surgery until discharge from hospital (approx. 7 days)]
• Perioperative mortality [Срок оценки: Within within 30 days after surgery]
• Change in brain injury biomarker panel [Срок оценки: At preoperative screening; at day of surgery; at postoperative day 1, 2 and 6 (or hospital discharge, whichever occurs first); between 6 weeks and 12 weeks after surgery]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 2 центра

• Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy — Basel
• Inselspital, Bern University Hospital — Bern

Великобритания · 2 центра

• Cambridge University Hospitals and Brain Physics Lab — Cambridge
• Royal Papworth Hospital, Department of Anaesthesia and Intensive Care — Cambridge

Публикации

• 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 neurolog PMID 41857828

Идентификаторы

NCT: NCT05595954 · 2022-01457; am22Gomes

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗