Background: This study was designed to evaluate the effects of a high-protein formula enriched with arginine, fiber, and antioxidants compared with a standard high-protein formula in early enteral nutrition in critically ill patients.
Methods: For this study, 220 patients were enrolled in a prospective, multicenter, single-blind, randomized trial in 15 Spanish intensive care units (ICUs). The primary end-points were the incidence density rates of nosocomial infections, ICU and hospital length of stay, ICU and in-hospital mortality, and mortality at 6-month follow-up.
Results: The patients in the control and study groups had similar baseline characteristics. The study group had a lower incidence of catheter-related sepsis (0.4 episodes/1000 ICU days) than the control group (5.5 episodes/1000 ICU days), with a relative risk (RR) of 0.07 (95% confidence interval [CI] 0.01 to 0.54, p < .001). There were no differences in the incidence of ventilator-associated pneumonia, surgical infection, bacteremia, or urinary tract infections between the 2 groups. ICU mortality (16% in the study group versus 21% in the control group; RR 1.5, CI 95% 0.7 to 2.9) and in-hospital mortality (21% in the study group versus 30% in the control group; RR 1.6, CI 95% 0.9 to 3) were similar without differences in survival at 6-month follow-up (75% in the study group versus 68% in the control group, p = .15). Patients in the study group who were treated for 2 or more days showed a strong trend for better survival at 6-month follow-up (76% in the study group versus 67% in the control group, p = .06). Medical patients treated with the study diet had better survival than medical patients in the control group (76% in the study group versus 59% in the control group, p < .05).
Conclusions: Critically ill patients fed a high-protein diet enriched with arginine, fiber, and antioxidants had a significantly lower catheter-related sepsis rate than patients fed a standard high-protein diet. There were no differences in mortality or ICU and hospital length of stay. The subgroup of patients fed the study diet for >2 days showed a trend toward decreased mortality.