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Randomized Controlled Trial
. 2022 Feb 16;26(1):46.
doi: 10.1186/s13054-022-03921-5.

Actively implementing an evidence-based feeding guideline for critically ill patients (NEED): a multicenter, cluster-randomized, controlled trial

Lu Ke #  1   2 Jiajia Lin #  1 Gordon S Doig  3 Arthur R H van Zanten  4 Yang Wang  5 Juan Xing  6 Zhongheng Zhang  7 Tao Chen  8 Lixin Zhou  9 Dongpo Jiang  10 Qindong Shi  11 Jiandong Lin  12 Jun Liu  13 Aibin Cheng  14 Yafeng Liang  15 Peiyang Gao  16 Junli Sun  17 Wenming Liu  18 Zhenyu Yang  19 Rumin Zhang  20 Wei Xing  21 An Zhang  22 Zhigang Zhou  23 Tingfa Zhou  24 Yang Liu  25 Fei Tong  26 Qiuhui Wang  27 Aijun Pan  28 Xiaobo Huang  29 Chuming Fan  30 Weihua Lu  31 Dongwu Shi  32 Lei Wang  33 Wei Li  34 Liming Gu  35 Yingguang Xie  36 Rongqing Sun  37 Feng Guo  38 Lin Han  39 Lihua Zhou  40 Xiangde Zheng  41 Feng Shan  42 Jianbo Liu  43 Yuhang Ai  44 Yan Qu  45 Liandi Li  42 Hailing Li  46 Zhiguo Pan  47 Donglin Xu  48 Zhiqiang Zou  49 Yan Gao  50 Chunli Yang  51 Qiuye Kou  52 Xijing Zhang  53 Jinglan Wu  54 Chuanyun Qian  55 Weixing Zhang  56 Minjie Zhang  57 Yuan Zong  58 Bingyu Qin  59 Fusen Zhang  60 Zhe Zhai  61 Yun Sun  62 Ping Chang  63 Bo Yu  64 Min Yu  65 Shiying Yuan  66 Yijun Deng  67 Liyun Zhao  68 Bin Zang  69 Yuanfei Li  70 Fachun Zhou  71 Xiaomei Chen  72 Min Shao  73 Weidong Wu  74 Ming Wu  75 Zhaohui Zhang  76 Yimin Li  77 Qiang Guo  78 Zhiyong Wang  79 Yuanqi Gong  80 Yunlin Song  81 Kejian Qian  82 Yongjian Feng  83 Baocai Fu  84 Xueyan Liu  85 Zhiping Li  86 Chuanyong Gong  87 Cheng Sun  88 Jian Yu  89 Zhongzhi Tang  90 Linxi Huang  91 Biao Ma  92 Zhijie He  93 Qingshan Zhou  94 Rongguo Yu  95 Zhihui Tong  96 Weiqin Li  97   98 Chinese Critcal Care Nutrition Trials Group (CCCNTG)
Collaborators, Affiliations
Randomized Controlled Trial

Actively implementing an evidence-based feeding guideline for critically ill patients (NEED): a multicenter, cluster-randomized, controlled trial

Lu Ke et al. Crit Care. .

Erratum in

  • Correction to: Actively implementing an evidence-based feeding guideline for critically ill patients (NEED): a multicenter, cluster-randomized, controlled trial.
    Ke L, Lin J, Doig GS, van Zanten ARH, Wang Y, Xing J, Zhang Z, Chen T, Zhou L, Jiang D, Shi Q, Lin J, Liu J, Cheng A, Liang Y, Gao P, Sun J, Liu W, Yang Z, Zhang R, Xing W, Zhang A, Zhou Z, Zhou T, Liu Y, Tong F, Wang Q, Pan A, Huang X, Fan C, Lu W, Shi D, Wang L, Li W, Gu L, Xie Y, Sun R, Guo F, Han L, Zhou L, Zheng X, Shan F, Liu J, Ai Y, Qu Y, Li L, Li H, Pan Z, Xu D, Zou Z, Gao Y, Yang C, Kou Q, Zhang X, Wu J, Qian C, Zhang W, Zhang M, Zong Y, Qin B, Zhang F, Zhai Z, Sun Y, Chang P, Yu B, Yu M, Yuan S, Deng Y, Zhao L, Zang B, Li Y, Zhou F, Chen X, Shao M, Wu W, Wu M, Zhang Z, Li Y, Guo Q, Wang Z, Gong Y, Song Y, Qian K, Feng Y, Fu B, Liu X, Li Z, Gong C, Sun C, Yu J, Tang Z, Huang L, Ma B, He Z, Zhou Q, Yu R, Tong Z, Li W; Chinese Critical Care Nutrition Trials Group (CCCNTG). Ke L, et al. Crit Care. 2022 Apr 21;26(1):115. doi: 10.1186/s13054-022-03982-6. Crit Care. 2022. PMID: 35449019 Free PMC article. No abstract available.

Abstract

Background: Previous cluster-randomized controlled trials evaluating the impact of implementing evidence-based guidelines for nutrition therapy in critical illness do not consistently demonstrate patient benefits. A large-scale, sufficiently powered study is therefore warranted to ascertain the effects of guideline implementation on patient-centered outcomes.

Methods: We conducted a multicenter, cluster-randomized, parallel-controlled trial in intensive care units (ICUs) across China. We developed an evidence-based feeding guideline. ICUs randomly allocated to the guideline group formed a local "intervention team", which actively implemented the guideline using standardized educational materials, a graphical feeding protocol, and live online education outreach meetings conducted by members of the study management committee. ICUs assigned to the control group remained unaware of the guideline content. All ICUs enrolled patients who were expected to stay in the ICU longer than seven days. The primary outcome was all-cause mortality within 28 days of enrollment.

Results: Forty-eight ICUs were randomized to the guideline group and 49 to the control group. From March 2018 to July 2019, the guideline ICUs enrolled 1399 patients, and the control ICUs enrolled 1373 patients. Implementation of the guideline resulted in significantly earlier EN initiation (1.20 vs. 1.55 mean days to initiation of EN; difference - 0.40 [95% CI - 0.71 to - 0.09]; P = 0.01) and delayed PN initiation (1.29 vs. 0.80 mean days to start of PN; difference 1.06 [95% CI 0.44 to 1.67]; P = 0.001). There was no significant difference in 28-day mortality (14.2% vs. 15.2%; difference - 1.6% [95% CI - 4.3% to 1.2%]; P = 0.42) between groups.

Conclusions: In this large-scale, multicenter trial, active implementation of an evidence-based feeding guideline reduced the time to commencement of EN and overall PN use but did not translate to a reduction in mortality from critical illness.

Trial registration: ISRCTN, ISRCTN12233792 . Registered November 20th, 2017.

Keywords: Cluster-randomized trial; Evidence-based guideline; Intensive care unit; Nutrition therapy.

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Conflict of interest statement

Dr. Gordon S. Doig reported receiving academic research grants related to nutrition in critical illness from the Australian National Health and Medical Research Council, Fresenius Kabi Deutschland GmbH and Baxter Healthcare Pty Ltd and speakers honoraria from Fresenius Kabi Deutschland GmbH, Baxter Healthcare Australia, Pty Ltd, Nestle Healthcare, Vevy, Switzerland and Nutricia Pharmaceutical (Wuxi) Co., Ltd. China. Dr. van Zanten reports personal fees from Baxter, personal fees from Nestle, personal fees from Fresenius Kabi, grants and personal fees from Nutricia, grants from Cardinal Health, grants from Mermaid, grants from Lyric, outside the submitted work. Dr. Weiqin Li reported receiving speakers honoraria from Nutricia Pharmaceutical (Wuxi) Co., Ltd. China. The remaining authors have disclosed that they do not have any conflicts of interest.

Figures

Fig. 1
Fig. 1
Evidence-based feeding guideline. A algorithm of the evidence-based feeding guideline. Feeding intolerance evaluation was implemented using the feeding intolerance score (Additional file 2: Table S1). GI denotes gastrointestinal, AGI denotes acute gastrointestinal injury, PN denotes parenteral nutrition, EN denotes enteral nutrition, and FIS denotes feeding intolerance score. B treatment of feeding intolerance. WBC denotes white blood cells, RBC denotes red blood cells, CD denotes Clostridium difficile, and D/C denotes discontinue
Fig. 2
Fig. 2
The flow of clusters (ICUs) and participants (patients) through the trial. ICU denotes intensive care unit
Fig. 3
Fig. 3
Nutritional support within the first seven days after enrollment. Error bars indicate test-based 95% confidence intervals (adjusted for cluster effect). a Proportion of patients receiving enteral and/or parenteral nutrition. P > 0.05 (adjusted for cluster effect) between feeding protocol and control groups at each day from day 1 to day 7. b Proportion of patients receiving enteral nutrition. P < 0.05 (adjusted for cluster effect) between feeding protocol and control groups at each day within seven days of enrollment except day 1. c Proportion of patients receiving parenteral nutrition P < 0.05 (adjusted for cluster effect) between feeding protocol and control groups at each day within seven days of enrollment

References

    1. McClave SA, Taylor BE, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, et al. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) JPEN J Parenter Enteral Nutr. 2016;40(2):159–211. doi: 10.1177/0148607115621863. - DOI - PubMed
    1. Reintam Blaser A, Starkopf J, Alhazzani W, Berger MM, Casaer MP, Deane AM, Fruhwald S, Hiesmayr M, Ichai C, Jakob SM, et al. Early enteral nutrition in critically ill patients: ESICM clinical practice guidelines. Intensive Care Med. 2017;43(3):380–398. doi: 10.1007/s00134-016-4665-0. - DOI - PMC - PubMed
    1. Doig GS, Simpson F, Finfer S, Delaney A, Davies AR, Mitchell I, Dobb G. Nutrition Guidelines Investigators of the ACTG: Effect of evidence-based feeding guidelines on mortality of critically ill adults: a cluster randomized controlled trial. JAMA. 2008;300(23):2731–2741. doi: 10.1001/jama.2008.826. - DOI - PubMed
    1. Heyland DK, Murch L, Cahill N, McCall M, Muscedere J, Stelfox HT, Bray T, Tanguay T, Jiang X, Day AG. Enhanced protein-energy provision via the enteral route feeding protocol in critically ill patients: results of a cluster randomized trial. Crit Care Med. 2013;41(12):2743–2753. doi: 10.1097/CCM.0b013e31829efef5. - DOI - PubMed
    1. Martin CM, Doig GS, Heyland DK, Morrison T, Sibbald WJ. Southwestern Ontario Critical Care Research N: Multicentre, cluster-randomized clinical trial of algorithms for critical-care enteral and parenteral therapy (ACCEPT) CMAJ. 2004;170(2):197–204. - PMC - PubMed

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