Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery
NCT ID: NCT07048002
Last Updated: 2025-11-24
Study Results
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Basic Information
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RECRUITING
NA
912 participants
INTERVENTIONAL
2025-07-06
2028-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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NeuroFirst target bundle
Management for NeuroFirst target bundle
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.
Routine Management
Management for institutional routine in accordance with published guidelines
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Receiving elective cardiovascular surgery with cardiopulmonary bypass
* Written Informed consent provided
Exclusion Criteria
* 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
60 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Responsible Party
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SHI Jia
Vice Chair, Department of Anesthesiology
Locations
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Beijing Chaoyang Hospital，Capital Medical University
Beijing, Beijing Municipality, China
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, China
Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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References
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Uysal S, Lin HM, Trinh M, Park CH, Reich DL. Optimizing cerebral oxygenation in cardiac surgery: A randomized controlled trial examining neurocognitive and perioperative outcomes. J Thorac Cardiovasc Surg. 2020 Mar;159(3):943-953.e3. doi: 10.1016/j.jtcvs.2019.03.036. Epub 2019 Mar 29.
Maheshwari A, McCormick PJ, Sessler DI, Reich DL, You J, Mascha EJ, Castillo JG, Levin MA, Duncan AE. Prolonged concurrent hypotension and low bispectral index ('double low') are associated with mortality, serious complications, and prolonged hospitalization after cardiac surgery. Br J Anaesth. 2017 Jul 1;119(1):40-49. doi: 10.1093/bja/aex095.
Descamps R, Amour J, Besnier E, Bougle A, Charbonneau H, Charvin M, Cholley B, Desebbe O, Fellahi JL, Frasca D, Labaste F, Lena D, Mahjoub Y, Mertes PM, Molliex S, Moury PH, Moussa MD, Oilleau JF, Ouattara A, Provenchere S, Rozec B, Parienti JJ, Fischer MO; OPTIPAM investigators. Perioperative individualized hemodynamic optimization according to baseline mean arterial pressure in cardiac surgery patients: Rationale and design of the OPTIPAM randomized trial. Am Heart J. 2023 Jul;261:10-20. doi: 10.1016/j.ahj.2023.03.005. Epub 2023 Mar 18.
Gerstenecker A, Norling AM, Jacob A, Lazar RM. Silent Brain Infarction, Delirium, and Cognition in Three Invasive Cardiovascular Procedures: a Systematic Review. Neuropsychol Rev. 2023 Jun;33(2):474-491. doi: 10.1007/s11065-022-09548-1. Epub 2022 Jul 8.
Newman MF, Kirchner JL, Phillips-Bute B, Gaver V, Grocott H, Jones RH, Mark DB, Reves JG, Blumenthal JA; Neurological Outcome Research Group and the Cardiothoracic Anesthesiology Research Endeavors Investigators. Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. N Engl J Med. 2001 Feb 8;344(6):395-402. doi: 10.1056/NEJM200102083440601.
Brown CH 4th, Probert J, Healy R, Parish M, Nomura Y, Yamaguchi A, Tian J, Zehr K, Mandal K, Kamath V, Neufeld KJ, Hogue CW. Cognitive Decline after Delirium in Patients Undergoing Cardiac Surgery. Anesthesiology. 2018 Sep;129(3):406-416. doi: 10.1097/ALN.0000000000002253.
Cheng C, Wan H, Cong P, Huang X, Wu T, He M, Zhang Q, Xiong L, Tian L. Targeting neuroinflammation as a preventive and therapeutic approach for perioperative neurocognitive disorders. J Neuroinflammation. 2022 Dec 12;19(1):297. doi: 10.1186/s12974-022-02656-y.
Indja B, Woldendorp K, Vallely MP, Grieve SM. Silent Brain Infarcts Following Cardiac Procedures: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2019 May 7;8(9):e010920. doi: 10.1161/JAHA.118.010920.
Vermeer SE, Prins ND, den Heijer T, Hofman A, Koudstaal PJ, Breteler MM. Silent brain infarcts and the risk of dementia and cognitive decline. N Engl J Med. 2003 Mar 27;348(13):1215-22. doi: 10.1056/NEJMoa022066.
Fanning JP, Wong AA, Fraser JF. The epidemiology of silent brain infarction: a systematic review of population-based cohorts. BMC Med. 2014 Jul 9;12:119. doi: 10.1186/s12916-014-0119-0.
Sultan I, Bianco V, Kilic A, Jovin T, Jadhav A, Jankowitz B, Aranda-Michel E, D'angelo MP, Navid F, Wang Y, Thoma F, Gleason TG. Predictors and Outcomes of Ischemic Stroke After Cardiac Surgery. Ann Thorac Surg. 2020 Aug;110(2):448-456. doi: 10.1016/j.athoracsur.2020.02.025. Epub 2020 Mar 19.
Other Identifiers
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The INSPIRE study
Identifier Type: -
Identifier Source: org_study_id
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