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：
8114637
负责人：
Thomas R Ziegler
金额：
$ 21.59万
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 2013-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8114637
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. PUBLIC HEALTH RELEVANCE: Nutrition support, either by the intravenous or gastrointestinal routes, is commonly given to hospital patients with critical illness, but the doses of energy (calories) that are associated with better clinical outcomes are unknown. This trial is designed to test the clinical effectiveness, especially on hospital infections, of different energy doses in critically ill adults who initially require intravenous feeding as part of their clinical care.

描述（由申请人提供）：本修订后的申请是为了响应 PA-09-151 消化系统疾病和营养方面的试点和可行性临床研究。在危重患者的营养支持方面，几乎没有进行严格的比较有效性研究（CER）。危重患者通常会接受专门的肠外或肠内（胃肠）营养，但不同能量（热量）剂量对于重要临床结果的比较功效尚不清楚。在重症监护病房 (ICU) 环境中，缺乏基于证据的数据和迄今为止研究中相互矛盾的信息导致临床医生为 ICU 患者提供的能量剂量范围很广。该试点研究旨在前瞻性测试不同能量剂量对危重内科和外科患者的临床疗效。我们还将生成新颖的、能够产生假设的连续血浆代谢组学数据。目标患者群体是住院内科或外科 ICU 中被认为最初需要静脉喂养的成年人。我们将评估能量剂量对 60 名需要专门营养支持的危重患者的医院获得性感染率和其他重要临床结果的影响。我们假设：1）充足的能量管理（定义为测量的静息能量消耗（REE）的 1.3 倍）与接受较低能量剂量的匹配 ICU 患者相比，与较低的医院感染率相关； 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整体变化。我们的具体目标是：1) 进行一项对照、双盲、前瞻性、随机 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 天住院时间的影响成人内科/外科 ICU 患者的获得性感染（主要终点）、血流感染和其他重要临床结果； 2) 检查累积和平均每日 28 天能量赤字（能量摄入 - 测量的 REE）对目标 1 临床结果终点的影响，以及与估计 REE 的关系（通过 Harris-Benedict 方程）； 3) 确定能量剂量和能量不足对代谢组模式的影响以及这些模式与目标 1 受试者临床结果的关联。公共卫生相关性：通常通过静脉或胃肠道途径向医院的重症患者提供营养支持，但与更好的临床结果相关的能量（卡路里）剂量尚不清楚。该试验旨在测试不同能量剂量对最初需要静脉喂养作为临床护理一部分的危重成人的临床效果，特别是对医院感染的效果。