Effect of Protein-Fortified Diet on Nitrogen Balance in Critically Ill Patients: Results from the OPINiB Trial.

Nitrogen balance (NB) is considered a good marker of adequate protein intake and it has been suggested to be a good predictor of patients' health outcomes. However, in literature, there is a lack of large randomized trials examining NB-guided protein intake in patients in intensive care units (ICUs). A randomized controlled trial enrolling patients admitted to ICU was done to compare changes in NB. Participants were randomized to a standard or protein-fortified diet (protein intake of 1.8 g/kg/day according to the guidelines of the Society of Critical Care Medicine and the American Society for Parenteral and Enteral Nutrition). The primary endpoint was represented by the NB on Day 1, 3, and study exit. Forty patients were enrolled in the study (19 in the protein-fortified group). The longitudinal analysis showed that, on Day 3, patients randomized to the protein-fortified diet were more likely (p < 0.001) to present better NB (at 3 days, patients in the protein-fortified diet were estimated to have a nitrate value of 5.22 g more than patients in the standard diet, 95% CI 3.86-6.58). The protein-fortified diet was found to be significantly and directly associated with changes in NB in critically ill patients admitted to ICU.