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Immediate vs. gradual advancement to goal of enteral nutrition after elective abdominal surgery: A multicenter non-inferiority randomized trial
The strategy of increasing the postoperative enteral nutrition dose to the target goal has not yet been clarified. This study aimed to determine whether an immediate goal-dose enteral nutrition (IGEN) strategy is non-inferior to a gradual goal-dose enteral nutrition (GGEN) strategy in reducing infec...
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Published in: | Clinical nutrition (Edinburgh, Scotland) Scotland), 2021-12, Vol.40 (12), p.5802-5811 |
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creator | Zhang, Li Liu, Yuxiu Gao, Xuejin Zhou, Da Zhang, Yupeng Tian, Feng Gao, Tingting Wang, Yong Chen, Zhida Lian, Bo Hu, Hao Jia, Zhenyi Xue, Zhigang Guo, Dong Zhou, Junde Gu, Yingchao Gong, Fangyou Wu, Xiaoting Tang, Yun Li, Mengbin Jin, Gang Qin, Huanlong Yu, Jianchun Zhou, Yanbing Chi, Qiang Yang, Hua Wang, Kunhua Li, Guoli Li, Ning van Zanten, Arthur R.H. Li, Jieshou Wang, Xinying |
description | The strategy of increasing the postoperative enteral nutrition dose to the target goal has not yet been clarified. This study aimed to determine whether an immediate goal-dose enteral nutrition (IGEN) strategy is non-inferior to a gradual goal-dose enteral nutrition (GGEN) strategy in reducing infections in patients undergoing abdominal surgery involving the organs of the digestive system.
This randomized controlled trial enrolled postoperative patients with nutritional risk screening 2002 scores ≥3 from 11 Chinese hospitals. Energy targets were calculated as 25 kcal/kg and 30 kcal/kg of ideal body weight for women and men, respectively. Patients were randomly assigned 1:1 to IGEN or GGEN group after enteral tolerance was confirmed (30% of the target on day 2). The IGEN group immediately started receiving 100% of the caloric requirements on day 3, while the GGEN group received 40% progressing to 80% of target on day 7. The primary endpoint was the infection rate until discharge, based on the intention-to-treat population.
A total of 411 patients were enrolled and randomized to the IGEN and GGEN groups, and five patients did not receive the allocated intervention. A total of 406 patients were included in the primary analysis, with 199 and 207 in the IGEN and GGEN groups, respectively. Infection was observed in 17/199 (8.5%) in the IGEN group and 19/207 (9.2%) in the GGEN group, respectively (difference, −0.6%; [95% confidence interval (CI), −6.2%–4.9%]; P = 0.009 for non-inferiority test). There were significantly more gastrointestinal intolerance events with IGEN than with GGEN (58/199 [29.1%] vs. 32/207 [15.5%], P |
doi_str_mv | 10.1016/j.clnu.2021.10.014 |
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This randomized controlled trial enrolled postoperative patients with nutritional risk screening 2002 scores ≥3 from 11 Chinese hospitals. Energy targets were calculated as 25 kcal/kg and 30 kcal/kg of ideal body weight for women and men, respectively. Patients were randomly assigned 1:1 to IGEN or GGEN group after enteral tolerance was confirmed (30% of the target on day 2). The IGEN group immediately started receiving 100% of the caloric requirements on day 3, while the GGEN group received 40% progressing to 80% of target on day 7. The primary endpoint was the infection rate until discharge, based on the intention-to-treat population.
A total of 411 patients were enrolled and randomized to the IGEN and GGEN groups, and five patients did not receive the allocated intervention. A total of 406 patients were included in the primary analysis, with 199 and 207 in the IGEN and GGEN groups, respectively. Infection was observed in 17/199 (8.5%) in the IGEN group and 19/207 (9.2%) in the GGEN group, respectively (difference, −0.6%; [95% confidence interval (CI), −6.2%–4.9%]; P = 0.009 for non-inferiority test). There were significantly more gastrointestinal intolerance events with IGEN than with GGEN (58/199 [29.1%] vs. 32/207 [15.5%], P < 0.001). All other secondary endpoints were non-significant.
Among postoperative patients at nutritional risk, IGEN was non-inferior to GGEN in regards to infectious complications. IGEN was associated with more gastrointestinal intolerance events. It showed that IGEN cannot be considered to be clinically directive. ClinicalTrials.gov (#NCT03117348).</description><identifier>ISSN: 0261-5614</identifier><identifier>EISSN: 1532-1983</identifier><identifier>DOI: 10.1016/j.clnu.2021.10.014</identifier><identifier>PMID: 34775223</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Abdomen - surgery ; Aged ; Cross Infection - epidemiology ; Dosing ; Elective abdominal surgery ; Elective Surgical Procedures - adverse effects ; Energy Intake ; Enteral nutrition ; Enteral Nutrition - adverse effects ; Enteral Nutrition - methods ; Female ; Humans ; Infections ; Male ; Middle Aged ; Nutritional risk ; Nutritional Status ; Postoperative Care - adverse effects ; Postoperative Care - methods ; Postoperative Complications - epidemiology</subject><ispartof>Clinical nutrition (Edinburgh, Scotland), 2021-12, Vol.40 (12), p.5802-5811</ispartof><rights>2021 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism</rights><rights>Copyright © 2021 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c356t-2df3b333af99f352d8904aab423cb3c13ccc7dadeacd2fa93881ed827e2993d3</citedby><cites>FETCH-LOGICAL-c356t-2df3b333af99f352d8904aab423cb3c13ccc7dadeacd2fa93881ed827e2993d3</cites><orcidid>0000-0001-6276-7192</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34775223$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zhang, Li</creatorcontrib><creatorcontrib>Liu, Yuxiu</creatorcontrib><creatorcontrib>Gao, Xuejin</creatorcontrib><creatorcontrib>Zhou, Da</creatorcontrib><creatorcontrib>Zhang, Yupeng</creatorcontrib><creatorcontrib>Tian, Feng</creatorcontrib><creatorcontrib>Gao, Tingting</creatorcontrib><creatorcontrib>Wang, Yong</creatorcontrib><creatorcontrib>Chen, Zhida</creatorcontrib><creatorcontrib>Lian, Bo</creatorcontrib><creatorcontrib>Hu, Hao</creatorcontrib><creatorcontrib>Jia, Zhenyi</creatorcontrib><creatorcontrib>Xue, Zhigang</creatorcontrib><creatorcontrib>Guo, Dong</creatorcontrib><creatorcontrib>Zhou, Junde</creatorcontrib><creatorcontrib>Gu, Yingchao</creatorcontrib><creatorcontrib>Gong, Fangyou</creatorcontrib><creatorcontrib>Wu, Xiaoting</creatorcontrib><creatorcontrib>Tang, Yun</creatorcontrib><creatorcontrib>Li, Mengbin</creatorcontrib><creatorcontrib>Jin, Gang</creatorcontrib><creatorcontrib>Qin, Huanlong</creatorcontrib><creatorcontrib>Yu, Jianchun</creatorcontrib><creatorcontrib>Zhou, Yanbing</creatorcontrib><creatorcontrib>Chi, Qiang</creatorcontrib><creatorcontrib>Yang, Hua</creatorcontrib><creatorcontrib>Wang, Kunhua</creatorcontrib><creatorcontrib>Li, Guoli</creatorcontrib><creatorcontrib>Li, Ning</creatorcontrib><creatorcontrib>van Zanten, Arthur R.H.</creatorcontrib><creatorcontrib>Li, Jieshou</creatorcontrib><creatorcontrib>Wang, Xinying</creatorcontrib><title>Immediate vs. gradual advancement to goal of enteral nutrition after elective abdominal surgery: A multicenter non-inferiority randomized trial</title><title>Clinical nutrition (Edinburgh, Scotland)</title><addtitle>Clin Nutr</addtitle><description>The strategy of increasing the postoperative enteral nutrition dose to the target goal has not yet been clarified. This study aimed to determine whether an immediate goal-dose enteral nutrition (IGEN) strategy is non-inferior to a gradual goal-dose enteral nutrition (GGEN) strategy in reducing infections in patients undergoing abdominal surgery involving the organs of the digestive system.
This randomized controlled trial enrolled postoperative patients with nutritional risk screening 2002 scores ≥3 from 11 Chinese hospitals. Energy targets were calculated as 25 kcal/kg and 30 kcal/kg of ideal body weight for women and men, respectively. Patients were randomly assigned 1:1 to IGEN or GGEN group after enteral tolerance was confirmed (30% of the target on day 2). The IGEN group immediately started receiving 100% of the caloric requirements on day 3, while the GGEN group received 40% progressing to 80% of target on day 7. The primary endpoint was the infection rate until discharge, based on the intention-to-treat population.
A total of 411 patients were enrolled and randomized to the IGEN and GGEN groups, and five patients did not receive the allocated intervention. A total of 406 patients were included in the primary analysis, with 199 and 207 in the IGEN and GGEN groups, respectively. Infection was observed in 17/199 (8.5%) in the IGEN group and 19/207 (9.2%) in the GGEN group, respectively (difference, −0.6%; [95% confidence interval (CI), −6.2%–4.9%]; P = 0.009 for non-inferiority test). There were significantly more gastrointestinal intolerance events with IGEN than with GGEN (58/199 [29.1%] vs. 32/207 [15.5%], P < 0.001). All other secondary endpoints were non-significant.
Among postoperative patients at nutritional risk, IGEN was non-inferior to GGEN in regards to infectious complications. IGEN was associated with more gastrointestinal intolerance events. It showed that IGEN cannot be considered to be clinically directive. ClinicalTrials.gov (#NCT03117348).</description><subject>Abdomen - surgery</subject><subject>Aged</subject><subject>Cross Infection - epidemiology</subject><subject>Dosing</subject><subject>Elective abdominal surgery</subject><subject>Elective Surgical Procedures - adverse effects</subject><subject>Energy Intake</subject><subject>Enteral nutrition</subject><subject>Enteral Nutrition - adverse effects</subject><subject>Enteral Nutrition - methods</subject><subject>Female</subject><subject>Humans</subject><subject>Infections</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Nutritional risk</subject><subject>Nutritional Status</subject><subject>Postoperative Care - adverse effects</subject><subject>Postoperative Care - methods</subject><subject>Postoperative Complications - epidemiology</subject><issn>0261-5614</issn><issn>1532-1983</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp9kc1u1DAUhS0EokPhBVggL9kk-CeZxIhNVfFTqRKb7q0b-3rkUWIX2xlpeAleGYcpLFnZPvrOkXwOIW85aznj-w_H1sxhbQUTvAot490zsuO9FA1Xo3xOdkzsedPveXdFXuV8ZIz1chhfkivZDUMvhNyRX3fLgtZDQXrKLT0ksCvMFOwJgsEFQ6El0kOsWnS0PjHVa1hL8sXHQMFVheKMpvgTUphsXHyoSF7TAdP5I72hyzoXb_54aYih8cFh8rEmnGmCsDl-oqU1EubX5IWDOeObp_OaPHz5_HD7rbn__vXu9ua-MbLfl0ZYJycpJTilnOyFHRXrAKZOSDNJw6UxZrBgEYwVDpQcR452FAMKpaSV1-T9JfYxxR8r5qIXnw3OMwSMa9aiV8OgVK9ERcUFNSnmnNDpx-QXSGfNmd520Ee97aC3HTat7lBN757y16n2-8_yt_gKfLoAWD958ph0Nh5r5dan2qW20f8v_zcLW53S</recordid><startdate>202112</startdate><enddate>202112</enddate><creator>Zhang, Li</creator><creator>Liu, Yuxiu</creator><creator>Gao, Xuejin</creator><creator>Zhou, Da</creator><creator>Zhang, Yupeng</creator><creator>Tian, Feng</creator><creator>Gao, Tingting</creator><creator>Wang, Yong</creator><creator>Chen, Zhida</creator><creator>Lian, Bo</creator><creator>Hu, Hao</creator><creator>Jia, Zhenyi</creator><creator>Xue, Zhigang</creator><creator>Guo, Dong</creator><creator>Zhou, Junde</creator><creator>Gu, Yingchao</creator><creator>Gong, Fangyou</creator><creator>Wu, Xiaoting</creator><creator>Tang, Yun</creator><creator>Li, Mengbin</creator><creator>Jin, Gang</creator><creator>Qin, Huanlong</creator><creator>Yu, Jianchun</creator><creator>Zhou, Yanbing</creator><creator>Chi, Qiang</creator><creator>Yang, Hua</creator><creator>Wang, Kunhua</creator><creator>Li, Guoli</creator><creator>Li, Ning</creator><creator>van Zanten, Arthur R.H.</creator><creator>Li, Jieshou</creator><creator>Wang, Xinying</creator><general>Elsevier Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-6276-7192</orcidid></search><sort><creationdate>202112</creationdate><title>Immediate vs. gradual advancement to goal of enteral nutrition after elective abdominal surgery: A multicenter non-inferiority randomized trial</title><author>Zhang, Li ; Liu, Yuxiu ; Gao, Xuejin ; Zhou, Da ; Zhang, Yupeng ; Tian, Feng ; Gao, Tingting ; Wang, Yong ; Chen, Zhida ; Lian, Bo ; Hu, Hao ; Jia, Zhenyi ; Xue, Zhigang ; Guo, Dong ; Zhou, Junde ; Gu, Yingchao ; Gong, Fangyou ; Wu, Xiaoting ; Tang, Yun ; Li, Mengbin ; Jin, Gang ; Qin, Huanlong ; Yu, Jianchun ; Zhou, Yanbing ; Chi, Qiang ; Yang, Hua ; Wang, Kunhua ; Li, Guoli ; Li, Ning ; van Zanten, Arthur R.H. ; Li, Jieshou ; Wang, Xinying</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c356t-2df3b333af99f352d8904aab423cb3c13ccc7dadeacd2fa93881ed827e2993d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Abdomen - surgery</topic><topic>Aged</topic><topic>Cross Infection - epidemiology</topic><topic>Dosing</topic><topic>Elective abdominal surgery</topic><topic>Elective Surgical Procedures - adverse effects</topic><topic>Energy Intake</topic><topic>Enteral nutrition</topic><topic>Enteral Nutrition - adverse effects</topic><topic>Enteral Nutrition - methods</topic><topic>Female</topic><topic>Humans</topic><topic>Infections</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Nutritional risk</topic><topic>Nutritional Status</topic><topic>Postoperative Care - adverse effects</topic><topic>Postoperative Care - methods</topic><topic>Postoperative Complications - epidemiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zhang, Li</creatorcontrib><creatorcontrib>Liu, Yuxiu</creatorcontrib><creatorcontrib>Gao, Xuejin</creatorcontrib><creatorcontrib>Zhou, Da</creatorcontrib><creatorcontrib>Zhang, Yupeng</creatorcontrib><creatorcontrib>Tian, Feng</creatorcontrib><creatorcontrib>Gao, Tingting</creatorcontrib><creatorcontrib>Wang, Yong</creatorcontrib><creatorcontrib>Chen, Zhida</creatorcontrib><creatorcontrib>Lian, Bo</creatorcontrib><creatorcontrib>Hu, Hao</creatorcontrib><creatorcontrib>Jia, Zhenyi</creatorcontrib><creatorcontrib>Xue, Zhigang</creatorcontrib><creatorcontrib>Guo, Dong</creatorcontrib><creatorcontrib>Zhou, Junde</creatorcontrib><creatorcontrib>Gu, Yingchao</creatorcontrib><creatorcontrib>Gong, Fangyou</creatorcontrib><creatorcontrib>Wu, Xiaoting</creatorcontrib><creatorcontrib>Tang, Yun</creatorcontrib><creatorcontrib>Li, Mengbin</creatorcontrib><creatorcontrib>Jin, Gang</creatorcontrib><creatorcontrib>Qin, Huanlong</creatorcontrib><creatorcontrib>Yu, Jianchun</creatorcontrib><creatorcontrib>Zhou, Yanbing</creatorcontrib><creatorcontrib>Chi, Qiang</creatorcontrib><creatorcontrib>Yang, Hua</creatorcontrib><creatorcontrib>Wang, Kunhua</creatorcontrib><creatorcontrib>Li, Guoli</creatorcontrib><creatorcontrib>Li, Ning</creatorcontrib><creatorcontrib>van Zanten, Arthur R.H.</creatorcontrib><creatorcontrib>Li, Jieshou</creatorcontrib><creatorcontrib>Wang, Xinying</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical nutrition (Edinburgh, Scotland)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zhang, Li</au><au>Liu, Yuxiu</au><au>Gao, Xuejin</au><au>Zhou, Da</au><au>Zhang, Yupeng</au><au>Tian, Feng</au><au>Gao, Tingting</au><au>Wang, Yong</au><au>Chen, Zhida</au><au>Lian, Bo</au><au>Hu, Hao</au><au>Jia, Zhenyi</au><au>Xue, Zhigang</au><au>Guo, Dong</au><au>Zhou, Junde</au><au>Gu, Yingchao</au><au>Gong, Fangyou</au><au>Wu, Xiaoting</au><au>Tang, Yun</au><au>Li, Mengbin</au><au>Jin, Gang</au><au>Qin, Huanlong</au><au>Yu, Jianchun</au><au>Zhou, Yanbing</au><au>Chi, Qiang</au><au>Yang, Hua</au><au>Wang, Kunhua</au><au>Li, Guoli</au><au>Li, Ning</au><au>van Zanten, Arthur R.H.</au><au>Li, Jieshou</au><au>Wang, Xinying</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Immediate vs. gradual advancement to goal of enteral nutrition after elective abdominal surgery: A multicenter non-inferiority randomized trial</atitle><jtitle>Clinical nutrition (Edinburgh, Scotland)</jtitle><addtitle>Clin Nutr</addtitle><date>2021-12</date><risdate>2021</risdate><volume>40</volume><issue>12</issue><spage>5802</spage><epage>5811</epage><pages>5802-5811</pages><issn>0261-5614</issn><eissn>1532-1983</eissn><abstract>The strategy of increasing the postoperative enteral nutrition dose to the target goal has not yet been clarified. This study aimed to determine whether an immediate goal-dose enteral nutrition (IGEN) strategy is non-inferior to a gradual goal-dose enteral nutrition (GGEN) strategy in reducing infections in patients undergoing abdominal surgery involving the organs of the digestive system.
This randomized controlled trial enrolled postoperative patients with nutritional risk screening 2002 scores ≥3 from 11 Chinese hospitals. Energy targets were calculated as 25 kcal/kg and 30 kcal/kg of ideal body weight for women and men, respectively. Patients were randomly assigned 1:1 to IGEN or GGEN group after enteral tolerance was confirmed (30% of the target on day 2). The IGEN group immediately started receiving 100% of the caloric requirements on day 3, while the GGEN group received 40% progressing to 80% of target on day 7. The primary endpoint was the infection rate until discharge, based on the intention-to-treat population.
A total of 411 patients were enrolled and randomized to the IGEN and GGEN groups, and five patients did not receive the allocated intervention. A total of 406 patients were included in the primary analysis, with 199 and 207 in the IGEN and GGEN groups, respectively. Infection was observed in 17/199 (8.5%) in the IGEN group and 19/207 (9.2%) in the GGEN group, respectively (difference, −0.6%; [95% confidence interval (CI), −6.2%–4.9%]; P = 0.009 for non-inferiority test). There were significantly more gastrointestinal intolerance events with IGEN than with GGEN (58/199 [29.1%] vs. 32/207 [15.5%], P < 0.001). All other secondary endpoints were non-significant.
Among postoperative patients at nutritional risk, IGEN was non-inferior to GGEN in regards to infectious complications. IGEN was associated with more gastrointestinal intolerance events. It showed that IGEN cannot be considered to be clinically directive. ClinicalTrials.gov (#NCT03117348).</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>34775223</pmid><doi>10.1016/j.clnu.2021.10.014</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-6276-7192</orcidid></addata></record> |
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subjects | Abdomen - surgery Aged Cross Infection - epidemiology Dosing Elective abdominal surgery Elective Surgical Procedures - adverse effects Energy Intake Enteral nutrition Enteral Nutrition - adverse effects Enteral Nutrition - methods Female Humans Infections Male Middle Aged Nutritional risk Nutritional Status Postoperative Care - adverse effects Postoperative Care - methods Postoperative Complications - epidemiology |
title | Immediate vs. gradual advancement to goal of enteral nutrition after elective abdominal surgery: A multicenter non-inferiority randomized trial |
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