Use of a concentrated enteral nutrition solution to increase calorie delivery to critically ill patients: a randomized, double-blind, clinical trial

• Published in: The American journal of clinical nutrition 2014-08, Vol.100 (2), p.616-625
• Main Authors: Peake, Sandra L, Davies, Andrew R, Deane, Adam M, Lange, Kylie, Moran, John L, O'Connor, Stephanie N, Ridley, Emma J, Williams, Patricia J, Chapman, Marianne J
• Format: Article
• Language: English
• Subjects: Adult; adverse effects; Aged; APACHE; Australia; clinical nutrition; Clinical outcomes; Clinical trials; Cohort Studies; Critical Care; diarrhea; Double-Blind Method; Energy Intake; enteral feeding; Enteral nutrition; Enteral Nutrition - adverse effects; Feasibility Studies; Female; fiber content; Food, Formulated - adverse effects; Food, Formulated - analysis; health status; Hospitals, University; Humans; Ideal Body Weight; Intensive Care Units; Male; men; Middle Aged; mortality; Patients; protein content; Respiration, Artificial; Survival Analysis
• ISSN: 0002-9165; 1938-3207
• DOI: 10.3945/ajcn.114.086322

Background: Critically ill patients typically receive ∼60% of estimated calorie requirements.Objectives: We aimed to determine whether the substitution of a 1.5-kcal/mL enteral nutrition solution for a 1.0-kcal/mL solution resulted in greater calorie delivery to critically ill patients and establish the feasibility of conducting a multicenter, double-blind, randomized trial to evaluate the effect of an increased calorie delivery on clinical outcomes.Design: A prospective, randomized, double-blind, parallel-group, multicenter study was conducted in 5 Australian intensive care units. One hundred twelve mechanically ventilated patients expected to receive enteral nutrition for ≥2 d were randomly assigned to receive 1.5 (n = 57) or 1.0 (n = 55) kcal/mL enteral nutrition solution at a rate of 1 mL/kg ideal body weight per hour for 10 d. Protein and fiber contents in the 2 solutions were equivalent.Results: The 2 groups had similar baseline characteristics (1.5 compared with 1.0 kcal/mL). The mean (±SD) age was 56.4 ± 16.8 compared with 56.5 ± 16.1 y, 74% compared with 75% were men, and the Acute Physiology and Chronic Health Evaluation II score was 23 ± 9.1 compared with 22 ± 8.9. The groups received similar volumes of enteral nutrition solution [1221 mL/d (95% CI: 1120, 1322 mL/d) compared with 1259 mL/d (95% CI: 1143, 1374 mL/d); P = 0.628], which led to a 46% increase in daily calories in the group given the 1.5-kcal/mL solution [1832 kcal/d (95% CI: 1681, 1984 kcal/d) compared with 1259 kcal/d (95% CI: 1143, 1374 kcal/d); P < 0.001]. The 1.5-kcal/mL solution was not associated with larger gastric residual volumes or diarrhea. In this feasibility study, there was a trend to a reduced 90-d mortality in patients given 1.5 kcal/mL [11 patients (20%) compared with 20 patients (37%); P = 0.057].Conclusions: The substitution of a 1.0- with a 1.5-kcal/mL enteral nutrition solution administered at the same rate resulted in a 46% greater calorie delivery without adverse effects. The results support the conduct of a large-scale trial to evaluate the effect of increased calorie delivery on clinically important outcomes in the critically ill. This trial was registered at Australian New Zealand Clinical Trials (http://www.anzctr.org.au/) as ACTRN 12611000793910.