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

项目摘要 每年有超过75万美国人需要机械通气，重症监护室（ICU） 幸存者在出院后会经历严重的损伤，包括持续性肌肉损伤。 虚弱、身体功能受损、生活质量下降和长期生存率下降。 迫切需要新的策略来改善ICU患者的身体恢复。跨 北美，研究一再表明ICU患者营养不良且无法活动 在他们病重期间长期卧床休息然而，现有证据表明， 在患者入住ICU期间早期补充氨基酸和锻炼， 改善成果。更多的数据表明，如果将这两种干预措施结合起来， 协同作用，以改善肌肉质量和身体功能。一种结合的氨基酸 补充和运动干预尚未在危重患者中进行研究。因此我们 提出一项II期随机对照试验， 补充和早期床上踏车运动与重症患者的常规护理。 我们假设，这种新的联合干预将增加身体功能的时候， 出院;减少肌肉萎缩;改善氨基酸代谢和蛋白质合成; 改善与健康相关的生活质量、身体功能和医疗保健资源利用。 我们的初步数据表明，氨基酸和运动干预的可行性和安全性。的 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 自行车测力运动器械（已上市，并获得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。而且这 在危重病期间进行运动干预不会造成心肺风险。我们 研究团队反映了ICU护理的跨学科性质，在所有领域都具有世界一流的专业知识 包括重症监护营养;运动/康复; ICU护理，临床护理， 协调;氨基酸代谢测量;和身体组成分析。我们的团队已被 在协调多中心基于ICU的RCT方面拥有无与伦比的经验，并具有成功的既往经验 合作。因此，该团队完全有能力进行这项旨在改变 营养和运动在ICU的范例，并改善身体的结果越来越多 ICU幸存者

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.