An interventional study of Managements for NeuroFirst target bundle and Managements for institutional routine in Silent Brain Infarction, Neurocognitive Disorders and Cardiac Surgery, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Recruiting at 5 sites in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Not applicable, Interventional, and Prevention
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.
246 studies on the registry are indexed under Neurocognitive Disorders; 88 are open to participants now.
This study's planned enrollment of 912 is above the median of 72 across 150 interventional studies indexed under Neurocognitive Disorders.
Browse Neurocognitive Disorders studies →Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 141 studies on the registry; 48 are open to participants now.
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Exclusion criteria:
Management for NeuroFirst target bundle
Other: Managements for NeuroFirst target bundle
Management for institutional routine in accordance with published guidelines
Other: Managements for institutional routine
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.
MAP, BIS, cerebral rSO2 and arterial inflow temperature during CPB rewarming, will be managed according to institutional routine in accordance with published guidelines.
the 7-day incidence of new-onset silent brain infarction (SBI)
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.
Time frame: within 7 days postoperatively
Key Secondary Outcome: the 30-day incidence of perioperative neurocognitive disorders (PND)
The incidence of 30-day PND includes the incidence of postoperative delirium in hospital and perioperative neurocognitive disorders within 30 days after surgery
Time frame: within 30 days postoperatively
the 5-day incidence of postoperative delirium
the incedence of delirium evaluated by CAM/CAM-ICU
Time frame: within five days postoperatively
the 30-day incidence of new-onset overt stroke
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).
Time frame: within 30 days postoperatively
the 1-year incidence of new-onset overt stroke
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).
Time frame: within 1 year postoperatively
the 1-year incidence of perioperative neurocognitive disorders (PND)
the incidence of perioperative neurocognitive disorders (PND)
Time frame: within 1 year postoperatively
the 30-day composite incidence of major adverse events
Major adverse events refer to renal insufficiency, myocardial infarction, pulmonary embolism, seizure and all-cause mortality.
Time frame: within 30 days postoperatively
the 1-year composite incidence of major adverse events
Major adverse events refer to renal insufficiency, myocardial infarction, pulmonary embolism, seizure and all-cause mortality.
Time frame: within 1 year postoperatively
the 30-day incidence of transient ischemic attack (TIA)
TIA is defined as focal arterial ischemia with transient symptoms (lasting \<24 hours) and without evidence of infarction by pathology or imaging.
Time frame: within 30 days postoperatively
the 1-year incidence of transient ischemic attack (TIA)
TIA is defined as focal arterial ischemia with transient symptoms (lasting \<24 hours) and without evidence of infarction by pathology or imaging.
Time frame: within 1 year postoperatively
Length of stay (LOS) in intensive care unit (ICU)
Length of stay (LOS) in intensive care unit (ICU) postoperatively
Time frame: Perioperative
Length of stay (LOS) in hospital
Length of stay (LOS) in hospital postoperatively
Time frame: Perioperative
Hospitalization cost
Operative and postoperative hospitalization cost
Time frame: Perioperative
Plan to share: No — Individual participant data (IPD) will not be shared in order to protect participant privacy and confidentiality. Additionally, the consent obtained from participants does not include provisions for data sharing, in accordance with ethical guidelines and institutional policies.
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Chinese Academy of Medical Sciences, Fuwai Hospital