Cardiac Surgery, Neurocognitive Disorders, Neuroprotective, Silent Brain Infarction
Conditions
Brief summary
the purpose of the study is to investigate whether a combined anesthetic targets bundle, known as the NeuroFirst strategy, focused on neurological protection, can reduce the incidence of silent brain infarction (SBI) and perioperative neurocognitive disorders (PND) in patients undergoing cardiac surgery. Additionally, the trial will assess the safety of this strategy. The NeuroFirst target bundle incorporates multiple parameters, including mean arterial pressure (MAP), bispectral index (BIS), regional cerebral oxygen saturation (rSO2), and arterial inflow temperature during cardiopulmonary bypass. The primary question this study seeks to answer is: Does the NeuroFirst strategy reduce the incidence of SBI and PND in cardiac surgery? To address this, researchers will compare the NeuroFirst strategy with routine institutional practices based on published guidelines. Participants will be randomly assigned to either the NeuroFirst group or the routine care group. All participants will undergo magnetic resonance imaging (MRI), be assessed using the Confusion Assessment Method (CAM) and the Montreal Cognitive Assessment (MoCA), and be followed for up to one year postoperatively.
Interventions
OTHERManagements for NeuroFirst target bundle
In the intervention group, patient management aims to achieve the NeuroFirst target bundle, including 1) mean arterial pressure (MAP) 65-90 mmHg, 2) bispectral index (BIS) 40-60, 3) regional cerebral oxygen saturation (rSO2)≥ 60% , and 4) arterial inflow temperature \<37 ℃ and rewarming rate \< 0.5 ℃/min after exceeding 30℃ during CPB. To achieve this target bundle, pharmacologic agents, fluid resuscitation, blood transfusion, and other therapeutic modalities will be utilized. These interventions are guided by comprehensive intraoperative monitoring, including conventional hemodynamic monitoring, invasive or non-invasive cardiac output and vascular resistance assessments.
OTHERManagements for institutional routine
MAP, BIS, cerebral rSO2 and arterial inflow temperature during CPB rewarming, will be managed according to institutional routine in accordance with published guidelines.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female adult patients aged 60 years or older * Receiving elective cardiovascular surgery with cardiopulmonary bypass * Written Informed consent provided
Exclusion criteria
* Contraindication to MRI scanning * Not suitable for receiving interventions to achieve NeuroFirst target bundle * Unable to receive neuro-cognitive evaluation due to language, vision, or hearing impairments * Breastfeeding or pregnancy * Terminal illness with a life expectancy of less than 3 months * Mental or legal disability * current enrollment in other interventional study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the 7-day incidence of new-onset silent brain infarction (SBI) | within 7 days postoperatively | New-onset silent brain infarction refers to newly developed cerebral infarctions detected on MRI, compared with the preoperative MRI, in the absence of any corresponding clinical symptoms of cerebral infarction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the 1-year incidence of new-onset overt stroke | within 1 year postoperatively | Postoperative new-onset overt stroke was defined as any new ischemic or hemorrhagic cerebrovascular event after surgery with focal or global neurological (motor, sensory or cognitive) dysfunction lasting at least 24 h. And a broadened stroke definition also including neurological dysfunction of \<24 h duration with corresponding evidence of central nervous system hemorrhage or infarction (including pathological, imaging, or other objective evidence of cerebral, spinal cord or retinal focal ischemic injury in a defined vascular distribution). |
| the 1-year composite incidence of major adverse events | within 1 year postoperatively | Major adverse events refer to renal insufficiency, myocardial infarction, pulmonary embolism, seizure and all-cause mortality. |
| the 30-day incidence of transient ischemic attack (TIA) | within 30 days postoperatively | TIA is defined as focal arterial ischemia with transient symptoms (lasting \<24 hours) and without evidence of infarction by pathology or imaging. |
| the 1-year incidence of transient ischemic attack (TIA) | within 1 year postoperatively | TIA is defined as focal arterial ischemia with transient symptoms (lasting \<24 hours) and without evidence of infarction by pathology or imaging. |
| Key Secondary Outcome: the 30-day incidence of perioperative neurocognitive disorders (PND) | within 30 days postoperatively | The incidence of 30-day PND includes the incidence of postoperative delirium in hospital and perioperative neurocognitive disorders within 30 days after surgery |
| the 5-day incidence of postoperative delirium | within five days postoperatively | the incedence of delirium evaluated by CAM/CAM-ICU |
| the 30-day incidence of new-onset overt stroke | within 30 days postoperatively | Postoperative new-onset overt stroke was defined as any new ischemic or hemorrhagic cerebrovascular event after surgery with focal or global neurological (motor, sensory or cognitive) dysfunction lasting at least 24 h. And a broadened stroke definition also including neurological dysfunction of \<24 h duration with corresponding evidence of central nervous system hemorrhage or infarction (including pathological, imaging, or other objective evidence of cerebral, spinal cord or retinal focal ischemic injury in a defined vascular distribution). |
| the 1-year incidence of perioperative neurocognitive disorders (PND) | within 1 year postoperatively | the incidence of perioperative neurocognitive disorders (PND) |
| the 30-day composite incidence of major adverse events | within 30 days postoperatively | Major adverse events refer to renal insufficiency, myocardial infarction, pulmonary embolism, seizure and all-cause mortality. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization cost | Perioperative | Operative and postoperative hospitalization cost |
| Length of stay (LOS) in hospital | Perioperative | Length of stay (LOS) in hospital postoperatively |
| Length of stay (LOS) in intensive care unit (ICU) | Perioperative | Length of stay (LOS) in intensive care unit (ICU) postoperatively |
Countries
China
Contacts
Primary ContactJia Shi, M.D.
Outcome results
None listed