Nutrition and Exercise in Critical Illness (The NEXIS Trial): A Randomized Trial of Combined Cycle Ergometry and Amino Acids in the ICU

危重疾病中的营养和运动（NEXIS 试验）：ICU 中联合循环测力法和氨基酸的随机试验

• 批准号: 9906918
• 负责人: Daren Keith Heyland
• 金额: $ 70.98万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9906918
• 关键词: Advocate; American; Amino Acids; Area; Bed rest; Beds; Blinded; Body Composition; Calories; Cardiopulmonary; Care given by nurses; Caring; Chest; Clinical; Collaborations; Coma; Critical Care; Critical Illness; Data; Devices; Discipline of Nursing; Enrollment; Ergometry; Evaluation; Exercise; FDA approved; Family Caregiver; Funding; Future; Grant; Healthcare; Hospitalization; Hospitals; Immobilization; Impairment; Incidence; Infection; Intake; Intensive Care; Intensive Care Units; Intervention; Intravenous; Length of Stay; Mechanical ventilation; Mechanics; Medicine; Morbidity - disease rate; Muscle Weakness; Muscular Atrophy; Nature; North America; Observational Study; Outcome; Outcome Assessment; Patient Outcomes Assessments; Patients; Performance; Phase; Physical Function; Population; Positioning Attribute; Protein Biosynthesis; Proteins; Public Health; Quality of life; Randomized Controlled Trials; Recovery; Reporting; Research; Research Personnel; Research Proposals; Resources; Risk; Site; Societies; Supplementation; Survivors; Time; Walking; aging population; amino acid metabolism; base; care coordination; clinical care; clinical practice; comparison intervention; cost; critical care nursing; exercise intervention; exercise rehabilitation; experience; family burden; health care service utilization; health related quality of life; improved; improved outcome; innovation; metabolomics; mortality; muscle form; muscle strength; novel; nutrition; patient oriented; phase II trial; primary endpoint; primary outcome; protein intake; randomized trial; safety and feasibility; secondary endpoint; treatment as usual; treatment effect; ventilation

PROJECT SUMMARY More than 750,000 Americans require mechanical ventilation annually, and intensive care unit (ICU) survivors experience substantial impairments after hospital discharge, including persistent muscle weakness, impaired physical functioning, reduced quality of life, and decreased long-term survival. There is an urgent need for new strategies to improve the physical recovery of ICU patients. Across North America, studies repeatedly demonstrate that ICU patients are undernourished and immobilized via prolonged bed rest throughout their critical illness. However, available evidence suggests that both amino acid supplementation and exercise, implemented early during patients' ICU stay, may improve outcomes. Additional data demonstrate that, when combined, these two interventions may behave synergistically to improve muscle mass and physical functioning. A combined amino acid supplementation and exercise intervention has not been investigated in critically ill patients. Thus, we propose a Phase II randomized controlled trial of an innovative combination of intravenous amino acid supplementation and early in-bed cycle ergometry exercise versus usual care in critically ill patients. We hypothesize that this novel combined intervention will increase physical functioning at the time of hospital discharge; reduce muscle wasting; improve amino acid metabolism and protein synthesis; with improved health-related quality of life, physical functioning, and healthcare resource utilization. Our preliminary data show feasibility and safety of both the amino acid and exercise intervention. The combined intervention can be delivered to ICU patients, even if sedated or comatose, since the in-bed cycle ergometry exercise device (already commercially available and FDA-approved for this purpose) automatically adjusts between passive or active mode depending on patient status. Moreover, this exercise intervention does not pose cardiopulmonary risk when delivered during critical illness. Our research team reflects the interdisciplinary nature of ICU care, with world-class expertise in all areas of this grant, including critical care nutrition; exercise/rehabilitation; ICU nursing, clinical care, and coordination; amino acid metabolism measurement; and body composition analysis. Our team has unparalleled experience with coordinating multi-site ICU-based RCTs, and has successful prior collaborations. Hence, the team is well positioned to conduct this novel RCT that aims to change the paradigm for nutrition and exercise in the ICU and improve physical outcomes for the growing number of ICU survivors.

项目总结 每年超过75万美国人需要机械通风，重症监护病房(ICU) 幸存者在出院后经历了实质性的损伤，包括持续性肌肉 虚弱，身体功能受损，生活质量下降，长期存活率下降。 迫切需要新的策略来改善ICU患者的身体恢复。横穿 北美的研究一再表明，ICU患者营养不良，行动不便 在他们的危重疾病期间长时间卧床休息。然而，现有证据表明， 在患者入住ICU期间及早进行氨基酸补充和运动，可能会 改善结果。更多数据表明，当这两种干预措施结合在一起时，可能 协同行动，以改善肌肉质量和身体功能。一种结合氨基酸 危重患者的补充和运动干预尚未得到研究。因此，我们 提出一种创新的静脉注射氨基酸组合的II期随机对照试验 危重病患者的补充和早期卧床周期测功性运动与常规护理的比较。 我们假设，这种新的联合干预措施将在 出院；减少肌肉损耗；改善氨基酸代谢和蛋白质合成； 与健康相关的生活质量、身体功能和医疗资源利用率的提高。 我们的初步数据显示了氨基酸和运动干预的可行性和安全性。这个 联合干预可以提供给ICU患者，即使是镇静或昏迷，因为在床上 自行车测功器(已经上市，FDA批准用于此目的) 根据患者状态在被动或主动模式之间自动调整。此外，这一点 运动干预在危重疾病期间进行时不会造成心肺风险。我们的 研究团队反映了ICU护理的跨学科性质，在所有领域都拥有世界级的专业知识 包括重症护理营养、运动/康复、ICU护理、临床护理和 协调；氨基酸代谢测量；和身体成分分析。我们队有 在协调基于ICU的多站点RCT方面具有无与伦比的经验，并具有成功的经验 合作。因此，该团队处于有利地位，可以实施这一旨在改变 ICU中营养和锻炼的范例，并改善越来越多的人的身体状况 重症监护室的幸存者。