A prospective, randomized, double-blind, controlled clinical trial of enteral immunonutrition in the critically ill

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Abstract

Objective

To assess the effects of enteral immunonutrition (IMN) on hospital mortality and length of stay in a heterogeneous group of critically ill patients.

Design

Prospective, randomized, double-blind, controlled clinical trial with an a priori subgroup analysis according to the volume of feed delivered in the first 72 hrs of intensive care unit (ICU) admission.

Setting

A 13-bed adult general ICU in a London teaching hospital.

Patients

A total of 398 patients were enrolled and data from 390 patients (IMN = 193, control = 197) were used for an intention-to-treat analysis. There were 369 patients (IMN = 184, control = 185) who actually received some enteral nutrition, of whom 101 patients (IMN = 50, control = 51) received >2.5 L within 72 hrs of ICU admission. This latter group was defined as the successful "early enteral nutrition" group.

Interventions

Within 48 hrs of ICU admission, patients were randomized to receive either the IMN Impact[registered sign] (Novartis Nutrition), an enteral feed supplemented with arginine, purine nucleotides and omega-3 fatty acids, or an isocaloric, isonitrogenous control enteral feed.

Measurements and Results

There was no significant difference in hospital mortality rate between the two groups on an intention-to-treat analysis (Impact group 48%, control group 44%) nor in any other predefined subgroup analysis. However, patients randomized to receive the IMN had higher Acute Physiology and Chronic Health Evaluation II scores (20.1 +/- 7.1 vs. 18.7 +/- 7.1 [p = .07] intention-to-treat [n = 390]; 20.1 +/- 7.2 vs. 18.5 +/- 7.1 [p= .04] received feed [n = 369]). Of the 101 patients achieving early enteral nutrition, those patients fed with the IMN had a significant reduction in their requirement for mechanical ventilation compared with controls (median duration of ventilation 6.0 and 10.5 days, respectively, p = .007) with an associated reduction in the length of hospital stay (medians 15.5 and 20 days, respectively, p = .03).

Conclusion

While the administration of enteral IMN to a general, critically ill population did not affect mortality, those patients in whom it was possible to achieve early enteral nutrition with Impact had a significant reduction in the morbidity of their critical illness. (Crit Care Med 1998; 26:1164-1172)

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