Effect of amino acid supplementation on short-term complications after gastrointestinal tumor surgery: the AMIGITS randomized clinical trial

Abstract

Abstract There is a scarcity of large randomized clinical trials on the efficacy and safety of high-dose amino acid supplementation (AAS) in patients with gastrointestinal tumors undergoing surgical treatment. To investigate the effect of high-dose amino acid supplementation on the incidence of infection within 30 days after major surgery in patients with gastrointestinal tumors. In this randomized clinical trial, we randomly assigned patients with gastrointestinal tumors to receive either AAS or standard care (SC). The primary outcome was the 30-day postoperative incidence of infection; secondary outcomes included amino acid treatment-related adverse events, in-hospital infectious complications, postoperative hospital stay, other complications, and laboratory test results. We included 407 patients in the intention-to-treat analysis for the primary outcome (AAS group, 204; SC group, 203). During the intervention, the actual mean daily energy intake did not differ significantly between the AAS and SC groups (25.53 vs 25.16 kcal/kg daily, P = .493). However, the actual mean daily amino acid intake was significantly higher in the AAS group than in the SC group (1.81 vs. 0.94 g/kg daily, P < .001). The infection incidence within 30 days of surgery was significantly lower in the AAS group than in the SC group (P = .025). The incidence of amino acid treatment-related adverse events and other complications 30 days postoperatively did not significantly differ between the two groups. The infection incidence during hospitalization was significantly lower in the AAS group than in the SC group (P = .033). Compared to the SC group, the AAS group had significantly shorter postoperative hospital stays (P < .001). AAS is associated with a reduced infection incidence within 30 days of major surgery in patients with gastrointestinal tumors and can be a promising strategy. Trial registration: Chictr.org.cn, ChiCTR2200056258.