OBJECTIVE: To study the effect of a high-protein enteral formula enriched with arginine, glutamine, and antioxidants and containing omega3 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.
RCT Entities:
OBJECTIVE: To study the effect of a high-protein enteral formula enriched with arginine, glutamine, and antioxidants and containing omega3 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.
Authors: Peter Andrews; Elie Azoulay; Massimo Antonelli; Laurent Brochard; Christian Brun-Buisson; Geoffrey Dobb; Jean-Yves Fagon; Herwig Gerlach; Johan Groeneveld; Jordi Mancebo; Philipp Metnitz; Stefano Nava; Jerome Pugin; Michael Pinsky; Peter Radermacher; Christian Richard; Robert Tasker Journal: Intensive Care Med Date: 2006-02-18 Impact factor: 17.440