Efficacy and Safety of SmofKabiven ® Versus Hospital-Compounded All-in-One Parenteral Nutrition in Chinese Patients Undergoing Gastrointestinal Surgery: A Multicenter, Randomized, Active-Controlled, Phase III Trial
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: This multicenter, randomized, non-inferiority phase III trial (NCT03792100) aimed to evaluate the efficacy and safety of SmofKabiven®, a three-chamber parenteral nutrition (PN) emulsion in adult patients undergoing gastrointestinal surgery. Eligible participants were randomized to either SmofKabiven® group (SEG) (n = 135) or hospital-compounded PN group (HCG) (n = 134) for five consecutive postoperative days. The primary endpoint was the change in serum prealbumin levels from baseline to day 6, with a non-inferiority margin of −2.75 mg/dL. By day 6, change of serum prealbumin levels from baseline was 3.22 mg/dl in the SEG and 2.74 mg/dl in the HCG, with a difference of 0.48 mg/dl (95% confidence interval: −0.80 to 1.77), indicating comparable improvement in nutritional status. Linoleic acid decreased more with SEG than that with HCG (between-group difference: −7.84 mg/l, P = 0.0128), while arachidonic acid decreased more with HCG (between-group difference: 0.38 mg/l, P = 0.0025). Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) were significantly higher with SEG (between-group difference: EPA, 0.48 mg/l, P < 0.0001; DHA, 0.64 mg/l, P < 0.0001, respectively), and taurine levels also increased significantly (between-group difference: 14.77 µM, P = 0.0217). Treatment-related adverse events were comparable in the two groups. SmofKabiven® was comparable to hospital-compounded PN in improving postoperative nutritional status and safety profile and its enrichment with omega-3 fatty acids and taurine may provide additional benefits.
Source: Nutrition and Cancer
Authors: Guocong Wu, Jiongqiang Huang, Xiaogang Zhong, Xiaogang Bi, Guohao Wu, Xudong Wang, Dejun Wu, Shijun Xiang, Liming Cheng, Jiawei He, Ying Chen, Hongwei Jia, Zhongtao Zhang
Institutions: Capital Medical University, Fudan University, National Clinical Research Center for Digestive Diseases, Zhongshan Hospital, Beijing Friendship Hospital, First Affiliated Hospital of Guangzhou Medical University, The People's Hospital of Guangxi Zhuang Autonomous Region, Shanxi Provincial People’s Hospital, Jilin University, Second Affiliated Hospital of Jilin University, Pudong Medical Center, Shanghai Jiao Tong University, Shanghai First People's Hospital, Fresenius Kabi (China)
Language: English
Subfield: Nutrition and Dietetics
Field: Nursing
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4411894111