Intensive Nutrition in ARDS: A Clinical Trial (INTACT)

描述(申请人提供)：入住重症监护病房(ICU)的急性呼吸窘迫综合征(ARDS)患者在住院期间体重大幅下降，并在出院后一年内出现营养相关的后遗症。然而，营养不良与这两种糟糕的结果都有关，然而，优化营养护理是否能扭转这一局面并改善这一人群的结果尚不清楚。为ARDS患者提供的营养护理通常包括在机械通气时进行肠内营养(EN)，然后在脱离呼吸机时进行普通饮食。EN是一种有风险和成本的医疗干预措施，但还没有研究证明它在这一人群中的有效性。此外，还没有研究评估一旦停用EN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来评估住进ICU的营养不良呼吸衰竭患者强化医疗营养治疗(IMNT)对短期和长期结果的影响。参与者(N=200)将随机接受标准护理(SC，如临时喂养标准食物)或在ICU入院后最初48小时内开始肠内营养时提供IMNT，并持续到75%的估计能量需求通过个性化的强化饮食疗法实现，以最大限度地增加口服摄入量，直到出院。住院期间评估的主要结果包括感染、在ICU和医院接受机械通气的天数以及各种免疫参数的变化。出院时，将评估出院后3个月和6个月参与者的脱脂质量(通过双能X射线吸收测量仪测量)、体重、肌肉无力(以手握力测量)、疲劳(以6分钟步行距离测量)的变化，以及各种免疫参数的变化。拟议的PRCT旨在评估营养不良是否独立导致发病率，以及IMNT是否可以扭转营养不良、改善免疫功能和其他临床结果。它采用了从ICU入院到出院的全面营养计划，将机械观察到的变化与免疫功能联系起来，并有可能扩大我们对改善短期(ICU内和住院期间)和ICU后长期发病率的方法的理解。它将为临床医生提供必要的重要翻译信息，以便为这些患者的营养护理提供循证医学，从床到床的实践。随着ICU存活率的提高和资源的稀缺，解决这些问题的研究具有很高的相关性。公共卫生相关性：入住重症监护病房(ICU)的呼吸衰竭患者在住院期间体重大幅下降，并在出院后一年内出现与营养相关的后遗症。拟议的临床试验将检查强化医疗营养治疗干预措施的影响，旨在减少这些营养下降对住院期间和出院后3个月和6个月的各种临床和免疫结果的影响。随着ICU存活率的提高和资源的稀缺，提供信息以指导实践以改善ICU逗留的短期和长期后果的研究是迫切需要的，而且具有高度的相关性。

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: 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.