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Randomized Controlled Trial Multicenter Study
Actively implementing an evidence-based feeding guideline for critically ill patients (NEED): a multicenter, cluster-randomized, controlled trial.
- Lu Ke, Jiajia Lin, Gordon S Doig, van ZantenArthur R HARHDepartment of Intensive Care Medicine, Gelderse Vallei Hospital, Willy Brandtlaan 10, 6716 RP, Ede, The Netherlands., Yang Wang, Juan Xing, Zhongheng Zhang, Tao Chen, Lixin Zhou, Dongpo Jiang, Qindong Shi, Jiandong Lin, Jun Liu, Aibin Cheng, Yafeng Liang, Peiyang Gao, Junli Sun, Wenming Liu, Zhenyu Yang, Rumin Zhang, Wei Xing, An Zhang, Zhigang Zhou, Tingfa Zhou, Yang Liu, Fei Tong, Qiuhui Wang, Aijun Pan, Xiaobo Huang, Chuming Fan, Weihua Lu, Dongwu Shi, Lei Wang, Wei Li, Liming Gu, Yingguang Xie, Rongqing Sun, Feng Guo, Lin Han, Lihua Zhou, Xiangde Zheng, Feng Shan, Jianbo Liu, Yuhang Ai, Yan Qu, Liandi Li, Hailing Li, Zhiguo Pan, Donglin Xu, Zhiqiang Zou, Yan Gao, Chunli Yang, Qiuye Kou, Xijing Zhang, Jinglan Wu, Chuanyun Qian, Weixing Zhang, Minjie Zhang, Yuan Zong, Bingyu Qin, Fusen Zhang, Zhe Zhai, Yun Sun, Ping Chang, Bo Yu, Min Yu, Shiying Yuan, Yijun Deng, Liyun Zhao, Bin Zang, Yuanfei Li, Fachun Zhou, Xiaomei Chen, Min Shao, Weidong Wu, Ming Wu, Zhaohui Zhang, Yimin Li, Qiang Guo, Zhiyong Wang, Yuanqi Gong, Yunlin Song, Kejian Qian, Yongjian Feng, Baocai Fu, Xueyan Liu, Zhiping Li, Chuanyong Gong, Cheng Sun, Jian Yu, Zhongzhi Tang, Linxi Huang, Biao Ma, Zhijie He, Qingshan Zhou, Rongguo Yu, Zhihui Tong, Weiqin Li, and Chinese Critcal Care Nutrition Trials Group (CCCNTG).
- Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, No. 305 Zhongshan East Road, Nanjing, 210000, Jiangsu Province, China.
- Crit Care. 2022 Feb 16; 26 (1): 46.
BackgroundPrevious 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.MethodsWe 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.ResultsForty-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.ConclusionsIn 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 RegistrationISRCTN, ISRCTN12233792 . Registered November 20th, 2017.© 2022. The Author(s).
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