Intensive Nutrition in ARDS: A Clinical Trial (INTACT)

ARDS 中的强化营养：临床试验 (INTACT)

• 批准号: 8099630
• 负责人: CAROL L BRAUNSCHWEIG
• 金额: $ 37.49万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-30 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8099630
• 关键词: Address; Admission activity; Adult Respiratory Distress Syndrome; Body Weight decreased; CD4 Positive T Lymphocytes; Clinical; Clinical Trials; Diet; Diet therapy; Enteral Nutrition; Fatigue; Fatty acid glycerol esters; Hand; Health; Hospitalization; Hospitals; Hour; Immune; Incidence; Infection; Intake; Intensive Care Units; Interleukin-10; Intervention; Length of Stay; Leptin; Link; Malnutrition; Measures; Mechanical ventilation; Medical; Medical Nutrition Therapy; Methods; Morbidity - disease rate; Muscle Weakness; Nutritional; Nutritional Support; Oral; Outcome; Participant; Patients; Population; Quality of life; Randomized; Regulatory T-Lymphocyte; Residual state; Resources; Respiratory Failure; Risk; Survival Rate; Travel; Ventilator Weaning; Walking; Weight; Weight Gain; bench to bedside; cost; design; feeding; food standard; grasp; immune function; improved; nutrition; primary outcome; programs; prospective; standard care; therapy design

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.

描述（由申请人提供）：因急性呼吸窘迫综合征（ARDS）而入住重症监护室（ICU）的患者在住院期间体重严重减轻，并在出院后长达一年的时间内出现营养相关残留效应。营养不良与这两种不良结局相关，然而，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局尚不清楚。向ARDS患者提供的营养护理通常包括机械通气时的肠内营养（EN），然后是脱离呼吸机后的一般饮食。EN是一种具有风险和成本的医疗干预，但没有研究证明其在该人群中的疗效。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，以评估强化医学营养治疗（IMNT）对入住ICU的营养不良呼吸衰竭患者的短期和长期结局的影响。受试者（N = 200）将随机接受标准护理（SC，例如标准食物的随意喂养）或IMNT（EN），在ICU入院的前48小时内开始，并持续接受IMNT，直至通过定制的个性化强化饮食治疗达到75%的估计能量需求，以最大限度地提高口服摄入量，直至出院。住院期间评估的主要结局包括感染、ICU和医院的机械通气天数以及各种免疫参数的变化。出院时、出院后3个月和6个月，将评估受试者的去脂肪质量（通过双能X线吸收测定法测量）、体重、肌无力（测量为握力）、疲劳（测量为出院时评估的6分钟步行距离）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是否可以逆转营养不良，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，将观察到的机械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）和长期ICU后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，以提供循证医学的营养护理，这些病人从板凳到床边的做法。随着ICU生存率的提高和资源的稀缺，解决这些问题的研究是高度相关的。公共卫生关系：因呼吸衰竭而进入重症监护室（ICU）的患者在住院期间体重严重减轻，并在出院后长达一年的时间内具有营养相关的残留效应。拟议的临床试验将研究强化医学营养治疗干预的影响，旨在减少住院期间和出院后3个月和6个月的各种临床和免疫结果的营养下降。随着ICU生存率的提高和资源的稀缺，迫切需要进行研究，以提供信息来指导可以改善ICU住院的短期和长期后果的实践，并且具有高度相关性。