Clinical outcome of immunonutrition in a heterogeneous intensive care population

Objective To study the effect of a high-protein enteral formula enriched with arginine, glutamine, and antioxidants and containing 3 fatty acids and a mixture of fibers, on the clinical outcome of a heterogeneous intensive care (ICU) population.Design and setting A randomized, prospective, double blind, controlled, two-center clinical trial in two intensive care units in The Netherlands.Patients and participants A total of 597 adult ICU patients expected to require enteral tube feeding for more than 2 days were randomized to receive immunonutrition or an isocaloric control formula. Interventions Patients received either the immunonutrition or the control feed.Measurements and results Intention-to-treat and per-protocol analyses showed no statistically significant difference in clinical outcome parameters between the two groups. Results of the intention-to-treat analysis in control vs. immunonutrition were: median ICU length of stay in days, 8.0 (IQR 5.0–16.0) vs. 7.0 (4.0–14.0); median hospital length of stay in days, 20.0 (IQR 10.0–34.0) vs. 20.0 (10.0–35.0); median days of ventilation, 6.0 (IQR 3.0–12.0) vs. 6.0 (IQR 3.0–12.0); ICU mortality, 26.8% vs. 28.2%; in-hospital mortality, 36.4% vs. 38.5%; infectious complications, 41.7% vs. 43.0%Conclusions The results of this largest randomized, controlled trial found that in the general ICU population immunonutrition has no beneficial effect on clinical outcome parameters. These results are consistent with the literature that is currently available.This revised version was published online in February 2005 with corrections to the heading of a subsection of the Results (A priori subgroup analyses).