Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery (PRECISION)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 4
- Primary Endpoint
- Change in 3D-CAM to assess postoperative delirium (POD)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (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.
Outcomes
Primary Outcomes
Change in 3D-CAM to assess postoperative delirium (POD)
Time Frame: Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier)
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.
Change in Confusion Assessment Method for the ICU (CAM-ICU) to assess postoperative delirium (POD)
Time Frame: Assessed daily on postoperative days 0 to 7 (or up to discharge, whichever occurs earlier)
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.
Secondary Outcomes
- Change in Montreal Cognitive Assessment (MoCA)(Between 6 weeks and 12 weeks, and up to 12 months after surgery)
- Length of hospital stay (in days)(From day of surgery until discharge from hospital (approx. 7 days))
- Intensive care unit (ICU) stay (in hours)(From day of surgery until discharge from ICU (approx. 1 day))
- 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))
- 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))
- Perioperative mortality(Within within 30 days after surgery)
- Change in brain injury biomarker panel(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)