Actively implementing an evidence-based feeding guideline for critically ill patients (NEED): a multicenter, cluster-randomized, controlled trial
Authors: Ke Lu , Lin Jiajia , Doig Gordon S. , van Zanten Arthur R. H. , Wang Yang , Xing Juan , Zhang Zhongheng , Chen Tao , Zhou Lixin , Jiang Dongpo , Shi Qindong , Lin Jiandong , Liu Jun , Cheng Aibin , Liang Yafeng , Gao Peiyang , Sun Junli , Liu Wenming , Yang Zhenyu , Zhang Rumin , Xing Wei , Zhang An , Zhou Zhigang , Zhou Tingfa , Liu Yang , Tong Fei , Wang Qiuhui , Pan Aijun , Huang Xiaobo , Fan Chuming , Lu Weihua , Shi Dongwu , Wang Lei , Li Wei , Gu Liming , Xie Yingguang , Sun Rongqing , Guo Feng , Han Lin , Zhou Lihua , Zheng Xiangde , Shan Feng , Liu Jianbo , Ai Yuhang , Qu Yan , Li Liandi , Li Hailing , Pan Zhiguo , Xu Donglin , Zou Zhiqiang , Gao Yan , Yang Chunli , Kou Qiuye , Zhang Xijing , Wu Jinglan , Qian Chuanyun , Zhang Weixing , Zhang Minjie , Zong Yuan , Qin Bingyu , Zhang Fusen , Zhai Zhe , Sun Yun , Chang Ping , Yu Bo , Yu Min , Yuan Shiying , Deng Yijun , Zhao Liyun , Zang Bin , Li Yuanfei , Zhou Fachun , Chen Xiaomei , Shao Min , Wu Weidong , Wu Ming , Zhang Zhaohui , Li Yimin , Guo Qiang , Wang Zhiyong , Gong Yuanqi , Song Yunlin , Qian Kejian , Feng Yongjian , Fu Baocai , Liu Xueyan , Li Zhiping , Gong Chuanyong , Sun Cheng , Yu Jian , Tang Zhongzhi , Huang Linxi , Ma Biao , He Zhijie , Zhou Qingshan , Yu Rongguo , Tong Zhihui , Li Weiqin ,   for the Chinese Critcal Care Nutrition Trials Group (CCCNTG), Ke Lu , Lin Jiajia , Tong Zhihui , Li Weiqin , Wang Yang , Xing Juan , Zhang Zhongheng , Guo Feng , Chen Tao , Zhou Lixin , Jiang Dongpo , Shi Qindong , Lin Jiandong , Liu Jun , Cheng Aibin , Liang Yafeng , Gao Peiyang , Sun Junli , Liu Wenming , Yang Zhenyu , Zhang Rumin , Xing Wei , Zhang An , Zhou Zhigang , Zhou Tingfa , Liu Yang , Tong Fei , Wang Qiuhui , Pan Aijun , Huang Xiaobo , Fan Chuming , Lu Weihua , Shi Dongwu , Wang Lei , Li Wei , Gu Liming , Xie Yingguang , Sun Rongqing , Han Lin , Zhou Lihua , Zheng Xiangde , Shan Feng , Li Liandi , Liu Jianbo , Ai Yuhang , Qu Yan , Li Hailing , Pan Zhiguo , Xu Donglin , Zou Zhiqiang , Gao Yan , Yang Chunli , Kou Qiuye , Zhang Xijing , Wu Jinglan , Qian Chuanyun , Zhang Weixing , Zhang Minjie , Feng Yongjian , Zong Yuan , Qin Bingyu , Zhang Fusen , Zhai Zhe , Sun Yun , Chang Ping , Yu Bo , Yu Min , Yuan Shiying , Deng Yijun , Zhao Liyun , Zang Bin , Li Yuanfei , Zhou Fachun , Chen Xiaomei , Shao Min , Wu Weidong , Wu Ming , Zhang Zhaohui , Li Yimin , Guo Qiang , Wang Zhiyong , Gong Yuanqi , Song Yunlin , Qian Kejian , Fu Baocai , Liu Xueyan , Li Zhiping , Gong Chuanyong , Sun Cheng , Yu Jian , Tang Zhongzhi , Huang Linxi , Ma Biao , He Zhijie , Zhou Qingshan , Yu Rongguo 
Published: February 2022

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.