PeriOperative Interventional Neuroprotection Trial-POINT

围手术期介入神经保护试验点

• 批准号: 6620888
• 负责人: Mark Franklin Newman
• 金额: $ 55.31万
• 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/6620888
• 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(由调查人员提供)：认知障碍经常发生 在大约40万名接受心脏手术的患者的手术后 每年都会进行手术。这些患者中越来越多的是老年人，而且 我们发现，这些患者群体特别容易患上 心脏手术后认知功能障碍。认知障碍最多的是 值得注意的是心脏手术后的早期阶段，但持续性发生在 重要的患者百分比。而形容词，如“微妙的，” “暂时性的”和“亚临床的”因为明显的暂时性而被使用 衰退的本质，我们已经确定围手术期的衰退与 五年后认知能力下降，生活质量下降。多重 临床和药理学方面的策略已被提出以减少 心脏手术相关的中枢神经系统功能障碍。然而， 大多数都是不成功的，或者是非常有限的成功，或者是不切实际的 根据适用于大多数患者的成本或风险-收益比。我们 将测试补充镁的能力，达到血浆水平的2倍 正常，为患者神经认知能力下降提供保护 正在接受心脏手术。这项临床试验将招募400多名患者 大约48个月。一系列神经认知测试以及 神经学评估将在基线、出院、4-6周、 术后1年。我们的多学科研究团队拥有广泛的 神经认知功能减退的短期和长期评估体会 心脏手术，将使这一项目迅速完成 作为试点临床和后续疗效试验。多项动物研究 证明镁在局部和全球缺血模型中的益处。 尽管仍处于早期登记阶段，但介入性镁中风研究 (图像)已经产生了令人振奋的结果。没有什么比这更具破坏性的了 病人，病人的家人或那些照顾病人的人 成功的手术可以延长生命，但会降低生命质量 延长生命。没有什么比这更有可能对生活质量产生负面影响了 比一个病人的病情恶化？S的精神状态，尤其是那些更高的 我们称之为认知的能力。因此，我们还将确定是否 围手术期镁丸加输液可改善生活质量 通过提高认知能力。我们提出了镁，通过一个 一系列可能的机制将使我们能够改变对 神经认知功能障碍，从而防止这种悲惨的后果 人口老龄化。