Intensive Nutrition in ARDS: A Clinical Trial (INTACT)

ARDS 中的强化营养：临床试验 (INTACT)

• 批准号: 8292040
• 负责人: CAROL L BRAUNSCHWEIG
• 金额: $ 37.11万
• 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 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8292040
• 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; 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; abstracting; bench to bedside; cost; design; feeding; food standard; grasp; immune function; improved; nutrition; primary outcome; programs; prospective; standard care; therapy design

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.

抽象的 因急性呼吸窘迫综合征入住重症监护病房 (ICU) 的患者 (ARDS) 住院期间体重明显减轻，并有营养相关残留 出院后一年内有效。营养不良与这两种不良结果有关，但是，如果 优化营养护理能否扭转这一局面并改善该人群的预后尚不清楚。 为 ARDS 患者提供的营养护理通常包括肠内营养 (EN) 脱离呼吸机后进行机械通气，然后进行一般饮食。 EN 是医学 干预措施存在风险和成本，但尚无研究证明其对这一人群的有效性。 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来评估重症医学的影响 短期和短期入住 ICU 的营养不良性呼吸衰竭患者的营养治疗 (IMNT) 长期成果。参与者 (N = 200) 将被随机分配接受标准护理 (SC 例如随意喂养标准食物）或在 ICU 的前 48 小时内开始 EN 时提供 IMNT 进入并持续，直到通过个性化、 强化饮食治疗旨在最大限度地增加口服摄入量，直至出院。主要结果 住院期间的评估包括感染情况、机械通气天数、在 ICU 中以及 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 将评估参与者的去脂质量变化（通过双能 X 射线测量） 吸收测定法）、体重、肌肉无力（以握力测量）、疲劳（以握力测量） 出院时评估 6 分钟步行距离以及各种免疫变化 参数。 拟议的 PRCT 旨在评估营养不良是否独立导致发病，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。它采用了一个 从入住ICU到出院的全面营养方案，链接变化 从机制上观察免疫功能，并有可能扩大我们对免疫功能的理解 改善短期（ICU 内和住院期间）和长期 ICU 后的方法 发病率。它将为临床医生提供 EBM 所需的重要翻译信息 这些患者从实验室到临床实践的营养护理。随着 ICU 存活率的提高 资源变得越来越稀缺，解决这些问题的研究具有高度相关性。项目叙述 因呼吸衰竭而入住重症监护病房 (ICU) 的患者患有以下疾病 住院期间体重明显减轻，并具有长达一年的营养相关残留效应 出院后。拟议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各种临床症状的营养下降 以及住院期间和出院后 3 个月和 6 个月的免疫学结果 释放。随着 ICU 存活率的提高和资源变得越来越稀缺，研究提供了 指导可以改善短期和长期后果的实践的信息 ICU 住院是急需且高度相关的。

项目成果

Suppressed cytokine production in whole blood cultures may be related to iron status and hepcidin and is partially corrected following weight reduction in morbidly obese pre-menopausal women.

全血培养物中细胞因子产生的抑制可能与铁状态和铁调素有关，并且在病态肥胖的绝经前女性体重减轻后得到部分纠正。

• DOI: 10.1016/j.cyto.2010.11.008
• 发表时间: 2011
• 期刊: Cytokine
• 影响因子: 3.8
• 作者: Tussing-Humphreys,Lisa;Pini,Maria;Ponemone,Venkatesh;Braunschweig,Carol;Fantuzzi,Giamila
• 通讯作者: Fantuzzi,Giamila

Response to Berger and Pichard and Heyland et al.

对 Berger、Pichard 和 Heyland 等人的回应。

• DOI: 10.1177/0148607114542832
• 发表时间: 2015
• 期刊: JPEN. Journal of parenteral and enteral nutrition
• 作者: Braunschweig,Carol;Sheean,Patricia;Peterson,SarahJ;Perez,SandraGomez;Freels,Sally;Lateef,Omar;Gurka,David;Fantuzzi,Giamila
• 通讯作者: Fantuzzi,Giamila

Examining the role of nutrition support and outcomes for hospitalized patients: putting nutrition back in the study design.

检查住院患者营养支持的作用和结果：将营养重新纳入研究设计中。

• DOI: 10.1016/j.jada.2010.08.019
• 发表时间: 2010
• 期刊: Journal of the American Dietetic Association
• 作者: Braunschweig,CarolA;Sheean,PatriciaM;Peterson,SarahJ
• 通讯作者: Peterson,SarahJ

Response to Dr Khursheed Jeejeebhoy.

对 Khursheed Jeejeebhoy 博士的回应。

• DOI: 10.1177/0148607114562889
• 发表时间: 2015
• 期刊: JPEN. Journal of parenteral and enteral nutrition
• 作者: Sheean,PatriciaM;Peterson,SarahJ;Perez,SandraGomez;Troy,KarenL;Patel,Ankur;Sclamberg,JoyS;Ajanaku,FolabomiC;Braunschweig,CarolA
• 通讯作者: Braunschweig,CarolA

Intensive nutrition in acute lung injury: a clinical trial (INTACT).

• DOI: 10.1177/0148607114528541
• 发表时间: 2015-01
• 期刊: JPEN. Journal of parenteral and enteral nutrition
• 作者: Braunschweig CA;Sheean PM;Peterson SJ;Gomez Perez S;Freels S;Lateef O;Gurka D;Fantuzzi G
• 通讯作者: Fantuzzi G