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

Официальное название

Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery (the INSPIRE Study)

Обзор

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.

Вмешательства

• Другое 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 interventio
• Другое 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.

Первичные конечные точки

• the 7-day incidence of new-onset silent brain infarction (SBI) [Срок оценки: within 7 days postoperatively]

Вторичные конечные точки (9)

• Key Secondary Outcome: the 30-day incidence of perioperative neurocognitive disorders (PND) [Срок оценки: within 30 days postoperatively]
• the 5-day incidence of postoperative delirium [Срок оценки: within five days postoperatively]
• the 30-day incidence of new-onset overt stroke [Срок оценки: within 30 days postoperatively]
• the 1-year incidence of new-onset overt stroke [Срок оценки: within 1 year postoperatively]
• the 1-year incidence of perioperative neurocognitive disorders (PND) [Срок оценки: within 1 year postoperatively]
• the 30-day composite incidence of major adverse events [Срок оценки: within 30 days postoperatively]
• the 1-year composite incidence of major adverse events [Срок оценки: within 1 year postoperatively]
• the 30-day incidence of transient ischemic attack (TIA) [Срок оценки: within 30 days postoperatively]
• the 1-year incidence of transient ischemic attack (TIA) [Срок оценки: within 1 year postoperatively]

Критерии участия

Критерии включения

• Male or female adult patients aged 60 years or older
• Receiving elective cardiovascular surgery with cardiopulmonary bypass
• Written Informed consent provided

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 5 центров

• Beijing Chaoyang Hospital，Capital Medical University — Пекин
• State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardio — Пекин
• Xuanwu Hospital,Capital Medical University — Пекин
• Beijing Tiantan Hospital, Capital Medical University — Пекин
• The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and — Ухань

Публикации

• 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. PMID 31056357
• 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. PMID 28974062
• 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 p PMID 36934980
• 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. PMID 35804216
• 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. PMID 11172175
• 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. PMID 29771710
• 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. PMID 36503642
• 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. PMID 31017035

Идентификаторы

NCT: NCT07048002 · The INSPIRE study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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