Early Parenteral Nutrition in Critically Ill Patients With Short-term Relative Contraindications to Early Enteral Nutrition A Randomized Controlled Trial

被引:366
作者
Doig, Gordon S. [1 ]
Simpson, Fiona [1 ]
Sweetman, Elizabeth A. [1 ]
Finfer, Simon R. [2 ]
Cooper, D. Jamie [3 ]
Heighes, Philippa T. [1 ]
Davies, Andrew R. [3 ]
O'Leary, Michael [4 ]
Solano, Tom [5 ]
Peake, Sandra [6 ]
机构
[1] Univ Sydney, Northern Clin Sch, Intens Care Res Unit, Sydney, NSW 2006, Australia
[2] Univ Sydney, George Inst Global Hlth, Sydney, NSW 2006, Australia
[3] Alfred Hosp, Melbourne, Vic, Australia
[4] Royal Prince Alfred Hosp, Sydney, NSW, Australia
[5] Westmead Hosp, Sydney, NSW, Australia
[6] Queen Elizabeth Hosp, Adelaide, SA, Australia
来源
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2013年 / 309卷 / 20期
基金
英国医学研究理事会;
关键词
CLINICAL-TRIALS; GUIDELINES; MORTALITY; THERAPY; QUALITY; HUMANS; ADULTS; DISUSE;
D O I
10.1001/jama.2013.5124
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Importance Systematic reviews suggest adult patients in intensive care units (ICUs) with relative contraindications to early enteral nutrition (EN) may benefit from parenteral nutrition (PN) provided within 24 hours of ICU admission. Objective To determine whether providing early PN to critically ill adults with relative contraindications to early EN alters outcomes. Design, Setting, and Participants Multicenter, randomized, single-blind clinical trial conducted between October 2006 and June 2011 in ICUs of 31 community and tertiary hospitals in Australia and New Zealand. Participants were critically ill adults with relative contraindications to early EN who were expected to remain in the ICU longer than 2 days. Interventions Random allocation to pragmatic standard care or early PN. Main Outcomes and Measures Day-60 mortality; quality of life, infections, and body composition. Results A total of 1372 patients were randomized (686 to standard care, 686 to early PN). Of 682 patients receiving standard care, 199 patients (29.2%) initially commenced EN, 186 patients (27.3%) initially commenced PN, and 278 patients (40.8%) remained unfed. Time to EN or PN in patients receiving standard care was 2.8 days (95% CI, 2.3 to 3.4). Patients receiving early PN commenced PN a mean of 44 minutes after enrollment (95% CI, 36 to 55). Day-60 mortality did not differ significantly (22.8% for standard care vs 21.5% for early PN; risk difference, -1.26%; 95% CI, -6.6 to 4.1; P=.60). Early PN patients rated day-60 quality of life (RAND-36 General Health Status) statistically, but not clinically meaningfully, higher (45.5 for standard care vs 49.8 for early PN; mean difference, 4.3; 95% CI, 0.95 to 7.58; P=.01). Early PN patients required fewer days of invasive ventilation (7.73 vs 7.26 days per 10 patient x ICU days, risk difference, -0.47; 95% CI, -0.82 to -0.11; P=.01) and, based on Subjective Global Assessment, experienced less muscle wasting (0.43 vs 0.27 score increase per week; mean difference, -0.16; 95% CI, -0.28 to -0.038; P=.01) and fat loss (0.44 vs 0.31 score increase per week; mean difference, -0.13; 95% CI, -0.25 to -0.01; P=.04). Conclusions and Relevance The provision of early PN to critically ill adults with relative contraindications to early EN, compared with standard care, did not result in a difference in day-60 mortality. The early PN strategy resulted in significantly fewer days of invasive ventilation but not significantly shorter ICU or hospital stays.
引用
收藏
页码:2130 / 2138
页数:9
相关论文
共 38 条
[1]  
[Anonymous], EARL PN TRIAL HARR B
[2]   Stopping Randomized Trials Early for Benefit and Estimation of Treatment Effects Systematic Review and Meta-regression Analysis [J].
Bassler, Dirk ;
Briel, Matthias ;
Montori, Victor M. ;
Lane, Melanie ;
Glasziou, Paul ;
Zhou, Qi ;
Heels-Ansdell, Diane ;
Walter, Stephen D. ;
Guyatt, Gordon H. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2010, 303 (12) :1180-1187
[3]   Estimating adjusted NNTs in randomised controlled trials with binary outcomes: A simulation study [J].
Bender, Ralf ;
Vervoelgyi, Volker .
CONTEMPORARY CLINICAL TRIALS, 2010, 31 (05) :498-505
[4]  
Bernard GR., 1995, AM J RESP CRIT CARE, V151, pA323
[5]   The international sepsis forum consensus conference on definitions of infection in the intensive care unit [J].
Calandra, T ;
Cohen, J .
CRITICAL CARE MEDICINE, 2005, 33 (07) :1538-1548
[6]   Early versus Late Parenteral Nutrition in Critically Ill Adults [J].
Casaer, Michael P. ;
Mesotten, Dieter ;
Hermans, Greet ;
Wouters, Pieter J. ;
Schetz, Miet ;
Meyfroidt, Geert ;
Van Cromphaut, Sophie ;
Ingels, Catherine ;
Meersseman, Philippe ;
Muller, Jan ;
Vlasselaers, Dirk ;
Debaveye, Yves ;
Desmet, Lars ;
Dubois, Jasperina ;
Van Assche, Aime ;
Vanderheyden, Simon ;
Wilmer, Alexander ;
Van den Berghe, Greet .
NEW ENGLAND JOURNAL OF MEDICINE, 2011, 365 (06) :506-517
[7]   Impact of early parenteral nutrition completing enteral nutrition in adult critically ill patients (EPaNIC trial): a study protocol and statistical analysis plan for a randomized controlled trial [J].
Casaer, Michael P. ;
Hermans, Greet ;
Wilmer, Alexander ;
Van den Berghe, Greet .
TRIALS, 2011, 12
[8]  
Cohen J, 2004, CRIT CARE MED, V32, P1510, DOI [10.1097/01.CCM.0000129973.13104.2D, 10.1097/01.CCM.0000145917.89975.F5]
[9]   WHAT IS SUBJECTIVE GLOBAL ASSESSMENT OF NUTRITIONAL-STATUS [J].
DETSKY, AS ;
MCLAUGHLIN, JR ;
BAKER, JP ;
JOHNSTON, N ;
WHITTAKER, S ;
MENDELSON, RA ;
JEEJEEBHOY, KN .
JOURNAL OF PARENTERAL AND ENTERAL NUTRITION, 1987, 11 (01) :8-13
[10]   Effect of Evidence-Based Feeding Guidelines on Mortality of Critically Ill Adults A Cluster Randomized Controlled Trial [J].
Doig, Gordon S. ;
Simpson, Fiona ;
Finfer, Simon ;
Delaney, Anthony ;
Davies, Andrew R. ;
Mitchell, Imogen ;
Dobb, Geoff .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2008, 300 (23) :2731-2741