Comparative effectiveness of energy dose in critical illness

能量剂量在危重疾病中的比较效果

基本信息

批准号：
8294603
负责人：
Thomas R Ziegler
金额：
$ 19.38万
依托单位：
EMORY UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-07-05 至 2015-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8294603
关键词：
Adult Advocate Calories Clinical Clinical Nutrition Clinical Research Clinical Trials Clinical effectiveness Conflict (Psychology)Critical Illness Data Digestive System Disorders Dose Double-Blind Method Drug Formulations Energy Intake Energy Metabolism Enteral Enteral Feeding Enteral Nutrition Equation Failure Fourier Transform Fractals Functional disorder Global Change Goals Guidelines Hospitals Intensive Care Units Intestines Intravenous Intravenous Feeding Liquid Chromatography Macronutrients Nutrition Malnutrition Mass Spectrum Analysis Measurement Measures Medical Metabolic Methods Micronutrients Modality Morbidity - disease rate Multicenter Trials Nature Nosocomial Infections Nuclear Magnetic Resonance Nutritional Observational Study Operative Surgical Procedures Outcome Parenteral Feedings Parenteral Nutrition Patients Pattern Phase Pilot Projects Plasma Prospective Studies Protein-Energy Malnutrition Protons Randomized Randomized Controlled Trials Regimen Research Rest Retrospective Studies Route Sepsis Societies Surgical Intensive Care Surveys Testing Time base clinical care clinical efficacy comparative effectiveness comparative efficacy design effectiveness research efficacy testing evidence base feeding gastrointestinal improved innovation metabolomics mortality novel novel strategies nutrient metabolism nutrition patient population prevent prospective research study response tube feeding

项目摘要

DESCRIPTION (provided by applicant): This revised application is in response to PA-09-151 Pilot and Feasibility Clinical Research Studies in Digestive Diseases and Nutrition. Little rigorous comparative effectiveness research (CER) has been performed in nutrition support of critically ill patients. Specialized parenteral or enteral (gastrointestinal) nutrition is routinely prescribed to critically ill patients, but the comparative efficacy of different energy (calorie) doses with regard to important clinical outcomes are unknown. In intensive care unit (ICU) settings, the lack of evidence-based data and conflicting information from studies to date contribute to the wide range of energy doses given to ICU patients by clinicians. This pilot study is designed to prospectively test the clinical efficacy of different energy doses in critically ill medical and surgical patients. We will also generate novel, hypothesis-generating serial plasma metabolomics data. The target patient population are adults hospitalized in medical or surgical ICUs deemed to initially require intravenous feeding. We will evaluate the impact of energy dose on the rate of hospital-acquired infection and other important clinical outcomes in a group of 60 critically ill patients requiring specialized nutrition support. We hypothesize that: 1) adequate energy administration, defined as 1.3 x measured resting energy expenditure (REE), will be associated with a lower hospital infection rate than in matched ICU patients receiving lower energy doses; and 2) differences in energy intake will result in global changes in plasma metabolic patterns that are associated with clinical outcomes. Our specific aims are: 1) to perform a controlled, double-blind, prospective, randomized 28-day clinical trial to test the impact of three energy doses (0.6, 1.0 and 1.3 x REE, respectively) on total 28-day hospital-acquired infections (primary endpoint), bloodstream infections and other important clinical outcomes in adult medical/surgical ICU patients; 2) to examine the effect of cumulative and mean daily 28-day energy deficits (energy intake - measured REE) on Aim 1 clinical outcome endpoints, and relationships with estimated REE (by the Harris-Benedict equation); and 3) to determine the effect of energy dose and energy deficits on metabolomic patterns and the association of these with Aim 1 subject clinical outcomes.

描述（由申请人提供）：此修订的应用是对PA-09-151试点和消化疾病和营养的可行性临床研究的响应。在重症患者的营养支持中，几乎没有严格的比较有效性研究（CER）。专门的肠胃外或肠内（胃肠道）营养通常是针对重症患者的，但是关于重要的临床结果的不同能量（卡路里）剂量的比较疗效尚不清楚。在重症监护病房（ICU）环境中，缺乏循证数据和迄今为止研究的信息相互矛盾，这有助于临床医生给ICU患者提供的各种能量剂量。这项试点研究旨在预期测试不同能量剂量在重症患者和手术患者中的临床疗效。我们还将生成新颖的，假设生成的串行等离子体代谢组学数据。目标患者群体是成年人在医疗或外科ICU中住院的，被认为最初需要静脉注射。我们将评估能量剂量对需要专门营养支持的60名重症患者的组件中医院获得感染率和其他重要临床结果的影响。我们假设：1）适当的能源给药，定义为1.3 x的静息能量消耗（REE），将与医院感染率较低相比，与接受较低能量剂量的ICU患者相比； 2）能量摄入的差异将导致与临床结果相关的血浆代谢模式的全球变化。我们的具体目的是：1）进行一项受控的，双盲的，前瞻性的28天临床试验，以测试三种能量剂量（分别为0.6、1.0和1.3 X REE）对总28天医院获得的感染（主要终结点），血液流动和其他重要的临床检查对成人医疗/成人术中心患者的影响； 2）检查累积和平均每日28天能量缺陷（能量摄入量REE）对AIM 1临床结果终点的影响，以及与估计的REE的关系（通过Harris-Benedict方程）； 3）确定能量剂量和能量缺陷对代谢组模式的影响，以及它们与AIM 1主体临床结果的关联。