Use of a High Protein Enteral Nutrition Formula to Increase Protein Delivery to Critically Ill Patients: A Randomized, Blinded, Parallel-group, Feasibility Trial.

BACKGROUND International guidelines recommend critically ill adults receive more protein than most usually receive. We aimed to establish the feasibility of a trial to evaluate whether feeding protein to international recommendations would improve outcomes, in which one group received protein doses representative of international guideline recommendations (high protein) and the other received doses similar to usual practice. METHODS We conducted a prospective, randomized, blinded, parallel-group feasibility trial across six intensive care units (ICUs). Critically ill mechanically ventilated adults expected to receive enteral nutrition (EN) for ≥2 days were randomized to receive EN containing 63 or 100 g protein/liter for ≤28 days. Data are mean (standard deviation) or median [interquartile range]. RESULTS The recruitment rate was 0.35 (0.13) patients/day with 120 patients randomized and data available for 116 (n = 58 per group). Protein delivery was greater in the high protein group (1.52 (0.52) vs 0.99 (0.27) g/kg IBW/day; difference 0.53 (95% CI 0.38 to 0.69) g/kg IBW/day), with no difference in calorie delivery (difference -26 (95% CI -190 to 137) kcal/kg IBW/day). There were no between-group differences in the duration of feeding (8.7 (7.3) vs 8.1 (6.3) days) and blinding of the intervention was confirmed. There were no differences in clinical outcomes including 90-day mortality (14/55 (26%) vs 15/56 (27%)); risk difference = -1.3 (95% CI -17.7 to 15.0) %. CONCLUSION It is feasible to conduct a multi-center blinded trial comparing the delivery of protein at international guideline recommended levels to doses similar to usual care during critical illness. This article is protected by copyright. All rights reserved.