Study of Nutritional Immune Support with Ensure Surgery Shake in Adults Undergoing LVAD Placement for Advanced Heart Failure

What this Trial Is About

Researchers are evaluating the effects of a nutritional immune modulating intervention, the Ensure Surgery Immunonutrition shake, on patients with advanced heart failure who are awaiting left ventricular assist device LVAD implantation. The study aims to understand how pre-surgical supplementation may influence the gut microbiome, systemic inflammation, malnutrition, and the risk of complications such as infections and mortality after LVAD surgery. This trial focuses on improving outcomes in hospitalized advanced heart failure patients through nutritional optimization before surgery. Participants will be divided based on their nutritional status assessed by AND-ASPEN criteria. Well-nourished patients are randomized to receive either one or three Ensure Surgery shakes daily from consent until LVAD implantation, while malnourished or at-risk patients receive three shakes daily. The intervention occurs in the preoperative period, aiming to optimize immune defense and nutrition before surgery. During the study, participants will have blood and stool samples collected at multiple time points before and after surgery, including baseline, day 5, pre-VAD, discharge around day 25, and post-discharge follow-up around day 55. Researchers will measure changes in gut microbial diversity, inflammatory markers such as C-reactive protein and various cytokines, and clinical outcomes including infections, intensive care unit length of stay, and mortality up to two years. This comprehensive monitoring will help assess the impact of nutritional supplementation on patient recovery and health after LVAD placement.

Enhanced Nutritional Optimization in LVAD Trial