Intensive Nutrition in ARDS: A Clinical Trial (INTACT)

摘要 因急性呼吸窘迫综合征入住重症监护室（ICU）的患者 （ARDS）在住院期间体重严重减轻，并有营养相关的残留 影响长达一年后出院。营养不良与这两种不良结局相关，然而，如果 优化营养护理是否可以扭转这种情况并改善这一人群的结果尚不清楚。 向ARDS患者提供的营养护理通常包括肠内营养（EN）， 机械通气，然后在脱离呼吸机时进行一般饮食。EN是一种医学 干预具有风险和成本，但没有研究表明其在这一人群中的有效性。 此外，没有研究评估EN停止后提供的营养护理的任何方面。 我们提出了一项前瞻性随机临床试验，以评估强化医疗的影响， 营养治疗（IMNT）对短期入住ICU的营养不良呼吸衰竭患者进行营养治疗 长期成果。参与者（N = 200）将随机接受标准治疗（SC 例如在ICU的前48小时内开始给予标准食物的自由进食）或作为EN提供的IMNT 入院并持续，直到通过个性化， 强化饮食治疗，以最大限度地提高口服摄入量，直到出院。主要结局 住院期间的评估包括感染、机械通气天数、ICU和 医院和各种免疫参数的变化。出院时、出院后3个月和6个月 将评估参与者的无脂肪质量的变化（通过双能X射线测量 吸收测定法）、体重、肌无力（以手握力测量）、疲劳（以 出院时评估的6分钟步行距离和各种免疫指标的变化 参数 拟议的减贫战略试验旨在评估营养不良是否独立导致发病， 如果IMNT能够逆转营养不良，改善免疫功能和其他临床结果。它采用 从ICU入院到出院的全面营养计划， 观察到的免疫功能的机制，并有可能扩大我们的理解， 改善短期（ICU内和住院期间）和长期ICU后的方法 病态它将为临床医生提供必要的重要翻译信息，以提供EBM， 这些病人的营养护理从工作台到床边的实践。ICU生存率提高 和资源变得更加稀缺，解决这些问题的研究是高度相关的。项目叙述 因呼吸衰竭而进入重症监护室（ICU）的患者患有 住院期间体重显著减轻，并有长达一年的营养相关残留影响 出院后拟议中的临床试验将检查强化医疗的影响， 营养治疗干预旨在减少这些营养下降的各种临床， 以及住院期间和住院后3个月和6个月的免疫学结局 放电随着ICU生存率的提高和资源的稀缺， 信息，以指导可以减轻短期和长期后果的做法， 重症监护室的住宿是迫切需要的，高度相关。

Abstract Patients admitted to the intensive care unit (ICU) with acute respiratory distress syndrome (ARDS) suffer from profound weight loss while hospitalized and have nutritional related residual effects up to a year post-discharge. Malnutrition is associated with both poor outcomes, however, if optimizing nutritional care can reverse this and improve outcomes in this population is not known. The nutritional care provided to ARDS patients typically consists of enteral nutrition (EN) while mechanically ventilated followed by a general diet when weaned from the ventilator. EN is a medical intervention that has risks and cost yet no studies have demonstrated its efficacy in this population. Further, no studies have evaluated any aspect of nutritional care provided once EN is discontinued. We propose a prospective randomized clinical trail to evaluate the impact of intensive medical nutrition therapy (IMNT) in malnourished respiratory failure patients admitted to the ICU on short and long-term outcomes. Participant's (N = 200) will be randomized to receive either standard care (SC e.g. ad lib feeding of standard food) or IMNT provided as EN started within the first 48 hours of ICU admission and continued until 75% of estimated energy needs are achieved via a individualized, intensive diet therapy tailored to maximize oral intake until hospital discharge. Primary outcomes evaluated while hospitalized include infections, days on mechanical ventilation, in the ICU and hospital and changes in various immune parameters. At discharge, 3- and 6-months post discharge participants will be assessed for changes in fat free mass (measured by dual energy x-ray absorptiometry), weight, muscular weakness (measured as hand grip strength), fatigue (measured as distanced traveled in 6-minute walk assessed at discharge and changes in various immune parameters. The proposed PRCT is designed to assess if malnutrition independently causes morbidity, and if IMNT can reverse malnutrition, improve immune function and other clinical outcomes. It employs a comprehensive nutrition program from ICU admission to hospital discharge, links the changes observed mechanistically to immune function and has the potential to expand our understanding of methods that improve both short-term (within the ICU and while hospitalized) and long-term post-ICU morbidities. It will provide the vital translational information necessary for clinicians to deliver EBM for the nutritional care of these patients from bench-to-bedside practice. As ICU survival rates improve and resources become scarcer studies addressing these issues are highly relevant. Project Narrative Patients admitted to the intensive care unit (ICU) with respiratory failure suffer from profound weight loss while hospitalized and have nutritional related residual effects up to a year post-discharge. The proposed clinical trial will examine the impact of an intensive medical nutrition therapy intervention designed to curtail these nutritional declines on various clinical as well as immunological outcomes while hospitalized and 3- and 6- months after hospital discharge. As ICU survival rates improve and resources become scarcer studies which provide information to guide practices that can ameliorate the short and long term consequences of the ICU stay are badly needed and highly relevant.