PHEnylephrine versus NOrepinephrine in Major NONcardiac surgery (PHENOMeNON): Foundational Studies for a Pragmatic Randomized Clinical Trial.

PHEnylephrine 与 NOrepinephrine 在主要非心脏手术 (PHENOMeNON) 中的比较：实用随机临床试验的基础研究。

• 批准号: 10570637
• 负责人: Allison Mary Janda
• 金额: $ 17.28万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-16 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10570637
• 关键词: Acute Renal Failure with Renal Papillary Necrosis; Adherence; Adoption; Adult; Affect; Anesthesia procedures; Anesthesiology; Attitude; Board Certification; Cardiac; Cardiovascular system; Clinical; Clinical Informatics; Clinical Trials; Clinical Trials Design; Data; Data Collection; Development; Discipline of obstetrics; Doctor of Philosophy; Echocardiography; Electronic Health Record; Fatigue; Fellowship; Functional disorder; Future; General Anesthesia; General anesthetic drugs; Goals; Health; Hospitals; Hypotension; Information Systems; Institution; Intensive Care Units; International; Interview; Intravenous; Investigation; Learning; Lung; Medical center; Medicine; Mental Depression; Mentors; Methods; Michigan; Myocardial; Norepinephrine; Operating Rooms; Operative Surgical Procedures; Organ; Outcome; Outcomes Research; Patient Care; Patients; Pattern; Perfusion; Perioperative; Perioperative Care; Peripheral; Phenylephrine; Physiological; Pilot Projects; Postoperative Period; Pragmatic clinical trial; Precision Medicine Initiative; Procedures; Protocols documentation; Provider; Research; Research Methodology; Research Personnel; Research Technics; Retrospective Studies; Safety; Sampling; Scientist; Series; Site; Stroke; Structure; Surveys; Testing; Training; United States National Institutes of Health; Universities; Variant; Vasoconstrictor Agents; career; chronic pain; design; improved; indexing; intravenous administration; knowledge base; member; myocardial injury; organ injury; pilot trial; pragmatic study; pragmatic trial; prospective; protocol development; randomized, clinical trials; risk minimization; skills; therapy design

ABSTRACT BACKGROUND: Approximately 60,000 patients undergo procedures requiring general anesthesia daily in the U.S., 60% of which require the administration of intravenous vasopressors to counteract general anesthesia- induced cardiovascular depression and low blood pressure (hypotension). Many studies have established the harmful effects of intraoperative hypotension, including myocardial injury, stroke, and acute kidney injury. Vasopressor therapies to treat intraoperative hypotension, specifically the choice between norepinephrine and phenylephrine, are debated vigorously. More studies are needed to better understand vasopressor selection and use and the impact of vasopressor selection on end-organ perfusion outcomes. RESEARCH: The goal of the proposed research is to conduct foundational studies to obtain essential background data and to conduct a pilot clinical trial. The first specific Aim is to perform a quantitative assessment of vasopressor practice patterns and variation across multiple institutions. This data will guide the sampling strategy of Aim 2, which explores attitudes and opinions of clinicians surrounding vasopressor selection at multiple institutions with a mixed methods approach. Aims 1 and 2 inform protocol development of a pilot study which allocates either norepinephrine or phenylephrine as the first-line vasopressor to be used to treat intraoperative hypotension conducted at the University of Michigan (UM) in Aim 3. The proposed research and training will provide Dr. Janda with the skills required to transition to an independent researcher. CANDIDATE: Dr. Allison Janda is a cardiothoracic anesthesiologist with board certification in anesthesiology and advanced perioperative echocardiography at UM. Through completion of a T32 Research Fellowship, Dr. Janda has begun to develop expertise in perioperative outcomes research, assessments of practice variation and clinical trials design. Her long-term career goal is to improve care for patients undergoing cardiac and major, non-cardiac surgery by better understanding and avoiding perioperative end-organ injury. ENVIRONMENT: UM is the coordinating center for the Multicenter Perioperative Outcomes Group (MPOG), an international consortium of over 50 institutions with perioperative information systems. Dr. Sachin Kheterpal, MD, MBA is a co-primary mentor for Dr. Janda, and is the Director for MPOG and member of the NIH Precision Medicine Initiative Advisory Panel. Dr. Daniel Clauw, MD is Dr. Janda’s other co-primary mentor and is the director of the Chronic Pain and Fatigue Research Center and founding director of the Michigan Institute for Clinical and Health Research. The proposed research will be completed under the guidance of her co-primary mentors, co-mentors including Dr. Michael Fetters, MD, and Dr. Graciela Mentz, PhD, and an advisory panel of experts in EHR data research, mixed methods research, and clinical trials.

摘要 背景：每天约有60,000名患者接受需要全身麻醉的手术。 其中60%需要静脉注射血管升压剂来对抗全身麻醉- 诱发心血管抑郁和低血压(低血压)。许多研究已经确立了 术中低血压的有害影响，包括心肌损伤、中风和急性肾损伤。 加压药治疗术中低血压，特别是在去甲肾上腺素和去甲肾上腺素之间的选择 苯肾上腺素，正在激烈地辩论。需要更多的研究来更好地了解血管加压剂的选择 以及血管加压剂的使用和对终末器官灌流结果的影响。 研究：拟议研究的目标是进行基础性研究，以获得必要的 背景数据，并进行试点临床试验。第一个具体目标是执行量化 评估血管加压剂的实践模式和跨多个机构的差异。这些数据将指导 Aim 2的抽样策略，探索临床医生对血管加压剂的态度和意见 在多个院校采用混合方法进行选拔。目标1和目标2通知协议的制定 一项先导性研究，将去甲肾上腺素或苯肾上腺素作为一线血管升压剂用于 治疗术中低血压在密歇根大学(UM)的目标3中进行。 培训将为詹达博士提供过渡到独立研究人员所需的技能。 候选人：艾莉森·扬达博士是一位拥有麻醉学证书的心胸麻醉师。 以及UM的先进的围手术期超声心动图。通过完成T32研究奖学金，Dr。 Janda已经开始在围手术期结果研究、实践差异评估方面发展专业知识 和临床试验设计。她的长期职业目标是改善对心脏和心脏手术患者的护理 通过更好地了解和避免围手术期终末器官损伤，进行重大、非心脏手术。 环境：UM是多中心围术期结局小组(MPOG)的协调中心 由50多家拥有围手术期信息系统的机构组成的国际财团。萨钦·卡什帕尔博士， MBA是Janda博士的联合初级导师，也是MPOG的主任和NIH Precision的成员 医学倡议咨询小组。医学博士Daniel Clauw是Janda博士的另一位共同小学导师，也是 慢性疼痛和疲劳研究中心主任，密歇根研究所创始主任 临床与健康研究。拟议的研究将在她的联合小学的指导下完成 导师，包括Michael Fetters博士和Graciela Mentz博士在内的共同导师，以及 EHR数据研究、混合方法研究和临床试验方面的专家。