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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
Main Authors: 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
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container_title Clinical nutrition (Edinburgh, Scotland)
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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 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 &lt; 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. 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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. 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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. 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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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