PeriOperative Interventional Neuroprotection Trial-POINT

围手术期介入神经保护试验点

• 批准号: 6422798
• 负责人: Mark Franklin Newman
• 金额: $ 55.26万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-12-01 至 2005-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6422798
• 关键词: aging; chemoprevention; clinical research; clinical trials; cognition disorders; coronary bypass; diet therapy; human subject; human therapy evaluation; magnesium; magnesium deficiency; neuroprotectants; neuropsychological tests; nutrition related tag; patient oriented research; postoperative complications; postoperative state

DESCRIPTION (provided by investigator): Cognitive impairment occurs frequently after surgery in the approximately 400,000 patients who undergo cardiac operations each year. An increasing number of these patients are elderly, and we have found that this patient population is particularly susceptible to cognitive dysfunction after cardiac surgery. Cognitive impairment is most notable in the early phases after cardiac surgery, but persistence occurs in an important percentage of patients. While adjectives such as "subtle," "transient," and "subclinical" have been used due to the apparent transient nature of decline, we have identified that perioperative decline is associated with five year cognitive deterioration and reduced quality of life. Multiple strategies, both clinical and pharmacological, have been proposed to reduce the central nervous system dysfunction associated with cardiac surgery. However, most have been unsuccessful, met with very limited success, or are unrealistic from a cost or risk-benefit ratio to be applied to the majority of patients. We will test the ability of supplemental magnesium, achieving plasma levels 2x normal, to provide protection from neurocognitive decline in patients undergoing cardiac surgery. This clinical trial will enroll 400 patients over approximately 48 months. A battery of neurocognitive tests as well as a neurologic assessment will be completed at baseline, discharge, 4 - 6 weeks, and one year postoperatively. Our multidisciplinary research team has extensive experience in assessing neurocognitive decline both short and long-term after cardiac surgery, will allow this project to be accomplished expeditiously both as a pilot clinical and following efficacy trial. Multiple animal studies demonstrate a benefit of magnesium in focal and global models of ischemia. Although still early in enrollment, the Interventional magnesium stroke study (IMAGES) has yielded promising results. Little is more devastating to a patient, the patient's family or those caring for a patient than to have a successful operation that prolongs life, but diminishes the quality of that prolonged life. Nothing is more likely to adversely impact the quality of life than deterioration in a patient?s mental status, particularly those higher faculties that we call cognition. Therefore, we will also determine if magnesium bolus plus infusion given perioperatively can improve quality of life through improved cognitive performance. We propose that magnesium, through one of a number of potential mechanisms will allow us to alter susceptibility to neurocognitive dysfunction and thereby prevent this tragic consequence in the aging population.

描述（由研究者提供）：经常发生认知障碍 在大约40万名接受心脏手术的患者中， 每年的业务。越来越多的患者是老年人， 我们发现，这一患者群体特别容易受到 心脏手术后的认知功能障碍认知障碍是最常见的 在心脏手术后的早期阶段值得注意，但持续性发生在 患者的重要比例。虽然“微妙”等形容词 由于明显的一过性，因此使用了“一过性”和“亚临床” 下降的性质，我们已经确定，围手术期下降与 五年认知能力下降生活质量下降多 已经提出了临床和药理学的策略来减少 与心脏手术相关的中枢神经系统功能障碍。然而，在这方面， 大多数都是不成功的，只取得了非常有限的成功，或者是不切实际的 从成本或风险收益比来应用于大多数患者。我们 将测试补充镁的能力，达到血浆水平2倍 正常，以防止患者神经认知功能下降 接受心脏手术这项临床试验将招募400名患者， 大约48个月。一系列神经认知测试以及 将在基线、出院、4 - 6周、 术后1年。我们的多学科研究团队拥有广泛的 在评估神经认知功能下降的短期和长期经验， 心脏手术，将使这个项目尽快完成， 作为先导性临床试验和后续疗效试验。多项动物研究 证明了镁在局部和整体缺血模型中的益处。 尽管仍处于早期招募阶段， （IATA）取得了可喜的成果。对一个 病人、病人家属或照顾病人的人， 成功的手术可以延长生命，但会降低生命的质量 延长寿命。没有什么比这更有可能对生活质量产生负面影响了 比病人病情恶化更重要吗的精神状态，尤其是那些 我们称之为认知的能力。因此，我们还将确定， 围手术期镁剂加静脉滴注可提高患者的生活质量 通过提高认知能力我们建议镁，通过一个 一些潜在的机制将使我们能够改变对 神经认知功能障碍，从而防止这种悲剧性的后果， 人口老龄化