Optimized calorie and high protein intake versus recommended caloric-protein intake in critically ill patients: a prospective, randomized, controlled phase II clinical trial

ABSTRACT Objective: To evaluate differences in outcomes for an optimized calorie and high protein nutrition therapy versus standard nutrition care in critically ill adult patients. Methods: We randomized patients expected to stay in the intensive care unit for at least 3 days. In the optimized calorie and high protein nutrition group, caloric intake was determined by indirect calorimetry, and protein intake was established at 2.0 to 2.2g/kg/day. The control group received 25kcal/kg/day of calories and 1.4 to 1.5g/kg/day protein. The primary outcome was the physical component summary score obtained at 3 and 6 months. Secondary outcomes included handgrip strength at intensive care unit discharge, duration of mechanical ventilation and hospital mortality. Results: In total, 120 patients were included in the analysis. There was no significant difference between the two groups in calories received. However, the amount of protein received by the optimized calorie and high protein nutrition group was significantly higher compared with the control group. The physical component summary score at 3 and 6 months did not differ between the two groups nor did secondary outcomes. However, after adjusting for covariates, a negative delta protein (protein received minus predetermined protein requirement) was associated with a lower physical component summary score at 3 and 6 months postrandomization. Conclusion: In this study optimized calorie and high protein strategy did not appear to improve physical quality of life compared with standard nutrition care. However, after adjusting for covariates, a negative delta protein was associated with a lower physical component summary score at 3 and 6 months postrandomization. This association exists independently of the method of calculation of protein target.