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Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery

NCT07048002 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 912

Last updated 2025-11-24

No results posted yet for this study

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.

Conditions

  • Silent Brain Infarction
  • Neurocognitive Disorders
  • Cardiac Surgery
  • Neuroprotective

Interventions

OTHER

Managements 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.

OTHER

Managements 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 & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-06
Primary Completion
2027-10-31
Completion
2028-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07048002 on ClinicalTrials.gov