TY - JOUR
T1 - Immediate vs. gradual advancement to goal of enteral nutrition after elective abdominal surgery
T2 - A multicenter non-inferiority randomized trial
AU - Zhang, Li
AU - Liu, Yuxiu
AU - Gao, Xuejin
AU - Zhou, Da
AU - Zhang, Yupeng
AU - Tian, Feng
AU - Gao, Tingting
AU - Wang, Yong
AU - Chen, Zhida
AU - Lian, Bo
AU - Hu, Hao
AU - Jia, Zhenyi
AU - Xue, Zhigang
AU - Guo, Dong
AU - Zhou, Junde
AU - Gu, Yingchao
AU - Gong, Fangyou
AU - Wu, Xiaoting
AU - Tang, Yun
AU - Li, Mengbin
AU - Jin, Gang
AU - Qin, Huanlong
AU - Yu, Jianchun
AU - Zhou, Yanbing
AU - Chi, Qiang
AU - Yang, Hua
AU - Wang, Kunhua
AU - Li, Guoli
AU - Li, Ning
AU - van Zanten, Arthur R.H.
AU - Li, Jieshou
AU - Wang, Xinying
PY - 2021/12
Y1 - 2021/12
N2 - Background & aims: 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. Methods: 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. Results: 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. Conclusions: 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).
AB - Background & aims: 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. Methods: 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. Results: 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. Conclusions: 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).
KW - Dosing
KW - Elective abdominal surgery
KW - Enteral nutrition
KW - Infections
KW - Nutritional risk
U2 - 10.1016/j.clnu.2021.10.014
DO - 10.1016/j.clnu.2021.10.014
M3 - Article
AN - SCOPUS:85118873664
SN - 0261-5614
VL - 40
SP - 5802
EP - 5811
JO - Clinical Nutrition
JF - Clinical Nutrition
IS - 12
ER -